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Mona Fiuzat

Mona Fiuzat

Adjunct Associate Professor in the Department of Medicine
Medicine, Clinical Pharmacology
mona.fiuzat@duke.edu
DUMC Box 3356, Durham, NC 27710
1530 Key Blvd, #124, Arlington, VA 22209

Selected Publications

Michael R. Bristow, MD, PhD

Journal Article Jacc Heart Failure · February 1, 2026 Full text Cite

Subgroups and Special Populations in Heart Failure Clinical Trials: Insights From the HFC-ARC Expert Consensus Panel.

Journal Article JACC Heart Fail · December 29, 2025 In the evolving landscape of heart failure (HF) management, the identification and analysis of subgroups and special populations within clinical trials are crucial for enhancing clinical decision-making, guiding further research, and understanding heteroge ... Full text Link to item Cite

Correction

Journal Article JACC · November 2025 Full text Cite

Prioritising the primary prevention of heart failure.

Journal Article Lancet · September 13, 2025 Heart failure remains one of the 21st century's greatest unmet clinical and public health challenges. Heart failure is a highly prevalent chronic condition that affects approximately 55 million people worldwide. Although heart failure can be prevented, the ... Full text Link to item Cite

Where's the Remote? Failure to Report Clinical Workflows in Heart Failure Remote Monitoring Studies.

Journal Article J Card Fail · September 2025 BACKGROUND: Remote patient monitoring (RPM) clinical trials have reported mixed results in improving outcomes for patients with chronic heart failure (HF). The impact of clinical workflows that could impact RPM effectiveness is often overlooked. We sought ... Full text Link to item Cite

Assessment of frailty in patients with heart failure: A new Heart Failure Frailty Score developed by Delphi consensus.

Journal Article ESC Heart Fail · June 2025 AIMS: The Heart Failure Frailty Score (HFFS) is a novel, multidimensional tool to assess frailty in patients with heart failure (HF). It has been developed to overcome limitations of existing frailty assessment tools while being practical for clinical use. ... Full text Link to item Cite

Derisking Phase II Clinical Trials in Heart Failure: A Position Paper from JACC: Basic to Translational Science and the Heart Failure Collaboratory.

Journal Article JACC Basic Transl Sci · May 2025 Phase II clinical trials play an important role in drug development, providing key data that guide decision-making for promising therapeutic candidates. An important objective of phase II is to establish proof of concept by demonstrating that the drug prod ... Full text Link to item Cite

Standardized Definitions of Changes in Kidney Function in Trials of Heart Failure: JACC Expert Panel From the HF-ARC.

Journal Article J Am Coll Cardiol · February 25, 2025 Perturbations in kidney function are frequently encountered in heart failure (HF) across its spectrum in both chronic and acute settings with distinct implications for patient management and prognosis. Lack of consensus on the threshold for clinically mean ... Full text Link to item Cite

Guideline-directed medical therapy implementation during hospitalization for cardiogenic shock.

Journal Article ESC Heart Fail · February 2025 AIMS: Despite significant morbidity and mortality, recent advances in cardiogenic shock (CS) management have been associated with increased survival. However, little is known regarding the management of patients who survive CS with heart failure (HF) with ... Full text Link to item Cite

Endpoint Selection in Randomized Clinical Trials for Hypertrophic Cardiomyopathy.

Journal Article JACC Heart Fail · February 2025 Randomized clinical trials (RCTs) for hypertrophic cardiomyopathy (HCM) have long been challenging caused by the condition's rarity, low event rates, and diverse clinical presentations. However, recent advances in targeted therapies have sparked increased ... Full text Link to item Cite

Artificial Intelligence in Cardiovascular Clinical Trials.

Journal Article J Am Coll Cardiol · November 12, 2024 Randomized clinical trials are the gold standard for establishing the efficacy and safety of cardiovascular therapies. However, current pivotal trials are expensive, lengthy, and insufficiently diverse. Emerging artificial intelligence (AI) technologies ca ... Full text Link to item Cite

Heart Failure Drug Development Over the Eras: From the Heart Failure Collaboratory.

Journal Article JACC Heart Fail · November 2024 Over the past decade, the field of heart failure (HF) has witnessed remarkable progress in drug development, resulting in the approval of numerous groundbreaking drugs by the U.S. Food and Drug Administration. To address some of these challenges, the U.S. ... Full text Link to item Cite

Optimal Medical Therapy and Outcomes Among Patients With Chronic Heart Failure With Reduced Ejection Fraction.

Journal Article JACC Heart Fail · November 2024 BACKGROUND: Optimal medical therapy (OMT) scoring may stratify clinical risk in real-world chronic heart failure with reduced ejection fraction (HFrEF) by integrating use and dosing of guideline-directed medical therapy (GDMT) for HFrEF. OBJECTIVES: The pu ... Full text Link to item Cite

Measures to Improve Trial Enrollment: It's Game Time!

Journal Article JACC Heart Fail · November 2024 Full text Link to item Cite

Training the Next Generation of Data Monitoring Committee Members: An Initiative of the Heart Failure Collaboratory.

Journal Article JACC Heart Fail · August 2024 Clinical trials are vital for assessing therapeutic interventions. The associated data monitoring committees (DMCs) safeguard patient interests and enhance trial integrity, thus promoting timely, reliable evaluations of those interventions. We face an urge ... Full text Link to item Cite

Clinical Trial Inclusion and Impact on Early Adoption of Medical Innovation in Diverse Populations.

Journal Article JACC Heart Fail · July 2024 BACKGROUND: Inadequate inclusion in clinical trial enrollment may contribute to health inequities by evaluating interventions in cohorts that do not fully represent target populations. OBJECTIVES: The aim of this study was to determine if characteristics o ... Full text Link to item Cite

Advancing Transthyretin Amyloidosis Drug Development in an Evolving Treatment Landscape: Amyloidosis Forum Meeting Proceedings.

Journal Article Adv Ther · July 2024 INTRODUCTION: Hereditary transthyretin amyloidosis (ATTRv, also referred to as hATTR; ORPHA 271861) and wild-type ATTR amyloidosis (ATTRwt; ORPHA 330001) are rare, progressive, systemic protein misfolding disorders with heterogeneous clinical presentations ... Full text Link to item Cite

Genitourinary Tract Infections in Patients Taking SGLT2 Inhibitors: JACC Review Topic of the Week.

Journal Article J Am Coll Cardiol · April 23, 2024 Sodium-glucose cotransporter-2 inhibitors (SGLT2is) have been shown to reduce adverse cardiovascular events in patients with type 2 diabetes mellitus, all-cause mortality, and heart failure hospitalization in patients with heart failure, as well as adverse ... Full text Link to item Cite

Left Ventricular Ejection Fraction and the Future of Heart Failure Phenotyping.

Journal Article JACC Heart Fail · March 2024 Heart failure (HF) is a complex syndrome traditionally classified by left ventricular ejection fraction (LVEF) cutpoints. Although LVEF is prognostic for risk of events and predictive of response to some HF therapies, LVEF is a continuous variable and cutp ... Full text Link to item Cite

Prognostic Impact of Repeated NT-proBNP Measurements in Patients With Heart Failure With Reduced Ejection Fraction.

Journal Article JACC Heart Fail · March 2024 BACKGROUND: Although clinical studies have demonstrated the association between a single N-terminal pro-B-type natriuretic peptide (NT-proBNP) measurement and clinical outcomes in chronic heart failure, the biomarker is frequently measured serially in clin ... Full text Link to item Cite

Standardized Definitions for Evaluation of Acute Decompensated Heart Failure Therapies: HF-ARC Expert Panel Paper.

Journal Article JACC Heart Fail · January 2024 Acute decompensated heart failure (ADHF) is one of the most common reasons for hospitalizations or urgent care and is associated with poor outcomes. Therapies shown to improve outcomes are limited, however, and innovation in pharmacologic and device-based ... Full text Link to item Cite

A CALL TO ACTION: HOW CAN CONGRESS HELP ENHANCE DIVERSITY IN CLINICAL TRIALS?

Conference JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY · 2024 Cite

TRAINING THE NEXT GENERATION: A NOVEL INITIATIVE FROM THE HEART FAILURE COLLABORATORY

Conference JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY · 2024 Cite

A CALL TO ACTION: HOW CAN CONGRESS HELP ENHANCE DIVERSITY IN CLINICAL TRIALS?

Conference JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY · 2024 Cite

TRAINING THE NEXT GENERATION: A NOVEL INITIATIVE FROM THE HEART FAILURE COLLABORATORY

Conference JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY · 2024 Cite

Heart failure medical therapy prior to mitral transcatheter edge-to-edge repair: the STS/ACC Transcatheter Valve Therapy Registry.

Journal Article Eur Heart J · November 21, 2023 BACKGROUND AND AIMS: Guideline-directed medical therapy (GDMT) is recommended before mitral valve transcatheter edge-to-edge repair (MTEER) in patients with heart failure (HF) and severe functional mitral regurgitation (FMR). Whether MTEER is being perform ... Full text Link to item Cite

Abstract 12936: Quality of Life Assessments as Inclusion Criteria in Heart Failure Clinical Trials

Conference Circulation · November 7, 2023 Background: Patient-reported quality of life (QoL) assessments, such as the Kansas City Cardiomyopathy Questionnaire (KCCQ) or Minnesota Living with Heart Failure Questionnaire (MLHFQ), reflect an ind ... Full text Cite

Polypharmacy and Optimization of Guideline-Directed Medical Therapy in Heart Failure: The GUIDE-IT Trial.

Journal Article JACC Heart Fail · November 2023 BACKGROUND: Polypharmacy is common among patients with heart failure with reduced ejection fraction (HFrEF). However, its impact on the use of optimal guideline-directed medical therapy (GDMT) is not well established. OBJECTIVES: This study sought to evalu ... Full text Link to item Cite

Circulating Angiokines Are Associated With Reverse Remodeling and Outcomes in Chronic Heart Failure.

Journal Article J Card Fail · June 2023 BACKGROUND: We sought to determine whether circulating modifiers of endothelial function are associated with cardiac structure and clinical outcomes in patients with heart failure with reduced ejection fraction (HFrEF). METHODS: We measured 25 proteins rel ... Full text Link to item Cite

Natriuretic peptides: role in the diagnosis and management of heart failure: a scientific statement from the Heart Failure Association of the European Society of Cardiology, Heart Failure Society of America and Japanese Heart Failure Society.

Journal Article Eur J Heart Fail · May 2023 Natriuretic peptides, brain (B-type) natriuretic peptide (BNP) and N-terminal prohormone of brain natriuretic peptide (NT-proBNP) are globally and most often used for the diagnosis of heart failure (HF). In addition, they can have an important complementar ... Full text Link to item Cite

Natriuretic Peptides: Role in the Diagnosis and Management of Heart Failure: A Scientific Statement From the Heart Failure Association of the European Society of Cardiology, Heart Failure Society of America and Japanese Heart Failure Society.

Journal Article J Card Fail · May 2023 Natriuretic peptides, brain (B-type) natriuretic peptide (BNP) and N-terminal prohormone of brain natriuretic peptide (NT-proBNP) are globally and most often used for the diagnosis of heart failure (HF). In addition, they can have an important complementar ... Full text Link to item Cite

A Composite Score Summarizing Use and Dosing of Evidence-Based Medical Therapies in Heart Failure: A Nationwide Cohort Study.

Conference Circ Heart Fail · February 2023 BACKGROUND: As heart failure therapeutic care becomes increasingly complex, a composite medical therapy score could be useful to conveniently summarize background medical therapy. We applied the composite medical therapy score developed by the Heart Failur ... Full text Link to item Cite

Managing Heart Failure in Patients on Dialysis: State-of-the-Art Review.

Journal Article J Card Fail · January 2023 Heart failure (HF) and end-stage kidney disease (ESKD) frequently coexist; 1 comorbidity worsens the prognosis of the other. HF is responsible for almost half the deaths of patients on dialysis. Despite patients' with ESKD composing an extremely high-risk ... Full text Link to item Cite

Patient-reported and Clinical Outcomes Among Patients Hospitalized for Heart Failure With Reduced Versus Preserved Ejection Fraction.

Journal Article J Card Fail · December 2022 BACKGROUND: Differences between patients hospitalized for heart failure with reduced ejection fraction (HFrEF) vs HF with preserved EF (HFpEF) are not well-characterized, particularly as pertains to in-hospital decongestion and longitudinal patient-reporte ... Full text Link to item Cite

Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel.

Journal Article JACC Heart Fail · December 2022 The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory (HFC) and the Academic Research Consortium (ARC) composed of patients, academic investigators from the United States and Europe, the U.S. Food and Drug ... Full text Link to item Cite

Titration of medical therapy and clinical outcomes among patients with heart failure with reduced ejection fraction: Findings from the HF-ACTION trial.

Journal Article Am Heart J · September 2022 BACKGROUND: Clinical guidelines recommend titration of angiotensin converting enzyme inhibitors (ACEi) and beta-blockers among patients with heart failure with reduced ejection fraction (HFrEF) to maximally tolerated doses. Patient characteristics associat ... Full text Link to item Cite

Effects of Dapagliflozin According to the Heart Failure Collaboratory Medical Therapy Score: Insights From DAPA-HF.

Journal Article JACC Heart Fail · August 2022 BACKGROUND: The Heart Failure Collaboratory (HFC) has developed a score integrating classes and doses of guideline-directed medical therapies prescribed for patients with heart failure (HF) and reduced ejection fraction. One potential use of this score is ... Full text Link to item Cite

Improving Enrollment of Underrepresented Racial and Ethnic Populations in Heart Failure Trials: A Call to Action From the Heart Failure Collaboratory.

Journal Article JAMA Cardiol · May 1, 2022 IMPORTANCE: Despite bearing a disproportionate burden of heart failure (HF), Black and Hispanic individuals have been poorly represented in HF clinical trials. Underrepresentation in clinical trials limits the generalizability of the findings to these popu ... Full text Link to item Cite

Spirituality in Patients With Heart Failure.

Journal Article JACC Heart Fail · April 2022 With advances in heart failure (HF) treatment, patients are living longer, putting further emphasis on quality of life (QOL) and the role of palliative care principles in their care. Spirituality is a core domain of palliative care, best defined as a dynam ... Full text Link to item Cite

Optimal Background Pharmacological Therapy for Heart Failure Patients in Clinical Trials: JACC Review Topic of the Week.

Journal Article J Am Coll Cardiol · February 8, 2022 With the current landscape of approved therapies for heart failure (HF), there is a need to determine the role of a standard background therapy against which novel therapies are studied. The Heart Failure Collaboratory convened a multistakeholder group of ... Full text Link to item Cite

Polypharmacy in Palliative Care for Advanced Heart Failure: The PAL-HF Experience.

Journal Article J Card Fail · February 2022 BACKGROUND: Palliative care (PC) in advanced heart failure (HF) aims to improve symptoms and quality of life (QOL), in part through medication management. The impact of PC on polypharmacy (>5 medications) remains unknown. METHODS AND RESULTS: We explored p ... Full text Link to item Cite

The influence of comorbidities on achieving an N-terminal pro-b-type natriuretic peptide target: a secondary analysis of the GUIDE-IT trial.

Journal Article ESC Heart Fail · February 2022 AIMS: N-terminal pro-b-type natriuretic peptide (NT-proBNP) values may be influenced by patient factors beyond the severity of illness, including atrial fibrillation (AF), renal dysfunction, or increased body mass index (BMI). We hypothesized that these fa ... Full text Link to item Cite

Race Differences in Quality of Life following a Palliative Care Intervention in Patients with Advanced Heart Failure: Insights from the Palliative Care in Heart Failure Trial.

Journal Article J Palliat Med · February 2022 Introduction: Black patients have a higher incidence of heart failure (HF) and worse outcomes than white patients. Guidelines recommend palliative care for patients with advanced HF, but no studies have examined outcomes in a black patient cohort. Methods: ... Full text Link to item Cite

Cost and Value in Contemporary Heart Failure Clinical Guidance Documents.

Journal Article JACC Heart Fail · January 2022 OBJECTIVES: This study sought to evaluate the frequency and nature of cost/value statements in contemporary heart failure (HF) clinical guidance documents (CGDs). BACKGROUND: In an era of rising health care costs and expanding therapeutic options, there is ... Full text Link to item Cite

Assessing race and ethnicity differences in outcomes based on GDMT and target NT-proBNP in patients with heart failure with reduced ejection fraction: An analysis of the GUIDE-IT study.

Journal Article Prog Cardiovasc Dis · 2022 BACKGROUND: The GUIDE-IT trial was, a multicenter, randomized, parallel group, unblinded study that randomized patients to having heart failure therapy titrated to achieve an NT-proBNP <1000 pg/mL or to usual clinical care. METHODS AND RESULTS: We performe ... Full text Link to item Cite

The Impact of Depression on Outcomes in Patients With Heart Failure and Reduced Ejection Fraction Treated in the GUIDE-IT Trial.

Journal Article J Card Fail · December 2021 BACKGROUND: It remains unclear why depression is associated with adverse outcomes in patients with heart failure (HF). We examine the relationship between depression and clinical outcomes among patients with HF with reduced ejection fraction managed with g ... Full text Link to item Cite

In-Hospital Initiation of Sodium-Glucose Cotransporter-2 Inhibitors for Heart Failure With Reduced Ejection Fraction.

Journal Article J Am Coll Cardiol · November 16, 2021 Sodium-glucose cotransporter-2 inhibitor therapy is well suited for initiation during the heart failure hospitalization, owing to clinical benefits that accrue rapidly within days to weeks, a strong safety and tolerability profile, minimal to no effects on ... Full text Link to item Cite

Use of Actigraphy (Wearable Digital Sensors to Monitor Activity) in Heart Failure Randomized Clinical Trials: A Scoping Review.

Journal Article Can J Cardiol · September 2021 BACKGROUND: Actigraphy-based measurements of physiologic parameters may enable design of patient-centric heart failure (HF) clinical trials. Recently, the Heart Failure Collaboratory focused on recommendations for meaningful change and use of actigraphy as ... Full text Link to item Cite

Intercountry Differences in Guideline-Directed Medical Therapy and Outcomes Among Patients With Heart Failure.

Journal Article JACC Heart Fail · July 2021 OBJECTIVES: The aim of this study was to examine patterns of care and clinical outcomes among patients with heart failure with reduced ejection fraction (HFrEF) in the United States and Canada. BACKGROUND: In the GUIDE-IT (Guiding Evidence Based Therapy Us ... Full text Link to item Cite

Does study subject diversity influence cardiology research site performance?: Insights from 2 U.S. National Coronary Stent Registries.

Journal Article Am Heart J · June 2021 BACKGROUND: Minorities and women are underrepresented in cardiovascular research. Whether their higher enrollment can be predicted or influences research site performance is unclear. METHODS: We evaluated 104 sites that enrolled 4,184 patients in the U.S. ... Full text Link to item Cite

The Cost-Effectiveness of Palliative Care: Insights from the PAL-HF Trial.

Journal Article J Card Fail · June 2021 BACKGROUND: In a randomized control trial, Palliative Care in Heart Failure (PAL-HF) improved heart failure-related quality of life, though cost-effectiveness remains unknown. The aim of this study was to evaluate the cost-effectiveness of the PAL-HF trial ... Full text Link to item Cite

Differences in NT-proBNP Response and Prognosis in Men and Women With Heart Failure With Reduced Ejection Fraction.

Journal Article J Am Heart Assoc · May 18, 2021 Background NT-proBNP (N-terminal pro-B-type natriuretic peptide) is a prognostic biomarker in heart failure (HF) with reduced ejection fraction. However, it is unclear whether there is a sex difference in NT-proBNP response and whether the therapeutic goal ... Full text Link to item Cite

Universal Definition and Classification of Heart Failure: A Report of the Heart Failure Society of America, Heart Failure Association of the European Society of Cardiology, Japanese Heart Failure Society and Writing Committee of the Universal Definition of Heart Failure.

Journal Article J Card Fail · April 2021 In this document, we propose a universal definition of heart failure (HF) as the following: HF is a clinical syndrome with symptoms and or signs caused by a structural and/or functional cardiac abnormality and corroborated by elevated natriuretic peptide l ... Full text Link to item Cite

Effects of Atrial Fibrillation on Heart Failure Outcomes and NT-proBNP Levels in the GUIDE-IT Trial.

Journal Article Mayo Clin Proc Innov Qual Outcomes · April 2021 OBJECTIVE: To evaluate effects of atrial fibrillation (AF) on cardiac biomarkers and outcomes in a trial population of patients with heart failure (HF) with reduced ejection fraction treated with optimal guideline-directed medical therapy. METHODS: We perf ... Full text Link to item Cite

Beta-blocker and ACE-inhibitor dosing as a function of body surface area: From the HF-ACTION trial.

Journal Article Am Heart J · March 2021 Recognizing that body surface area (BSA) is a commonly used metric to inform medication dosing across fields of medicine, it is possible that patients with heart failure with reduced ejection fraction (HFrEF) with higher BSA may be more likely to tolerate ... Full text Link to item Cite

Universal definition and classification of heart failure: a report of the Heart Failure Society of America, Heart Failure Association of the European Society of Cardiology, Japanese Heart Failure Society and Writing Committee of the Universal Definition of Heart Failure: Endorsed by the Canadian Heart Failure Society, Heart Failure Association of India, Cardiac Society of Australia and New Zealand, and Chinese Heart Failure Association.

Journal Article Eur J Heart Fail · March 2021 In this document, we propose a universal definition of heart failure (HF) as a clinical syndrome with symptoms and/or signs caused by a structural and/or functional cardiac abnormality and corroborated by elevated natriuretic peptide levels and/or objectiv ... Full text Link to item Cite

Treatment of HF in an Era of Multiple Therapies: Statement From the HF Collaboratory.

Journal Article JACC Heart Fail · January 2021 The treatment of heart failure with reduced ejection fraction (HFrEF) has changed considerably over time, particularly with the sequential development of therapies aimed at antagonism of maladaptive biologic pathways, including inhibition of the sympatheti ... Full text Link to item Cite

Putting the "Optimal" in Optimal Medical Therapy.

Journal Article JACC Heart Fail · January 2021 Full text Link to item Cite

Geographical affiliation with top 10 NIH-funded academic medical centers and differences between mortality from cardiovascular disease and cancer.

Journal Article Am Heart J · December 2020 Community engagement and rapid translation of findings for the benefit of patients has been noted as a major criterion for NIH decisions regarding allocation of funds for research priorities. We aimed to examine whether the presence of top NIH-funded insti ... Full text Link to item Cite

Standardized definitions for evaluation of heart failure therapies: scientific expert panel from the Heart Failure Collaboratory and Academic Research Consortium.

Journal Article Eur J Heart Fail · December 2020 The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory (HFC) and Academic Research Consortium (ARC), comprised of leading heart failure (HF) academic research investigators, patients, United States (US) Food ... Full text Link to item Cite

Utility of Restricted Mean Survival Time Analysis for Heart Failure Clinical Trial Evaluation and Interpretation.

Journal Article JACC Heart Fail · December 2020 OBJECTIVES: This study sought to demonstrate the statistical and utilitarian properties of restricted mean survival time (RMST) and restricted mean time lost (RMTL) for assessing treatments for heart failure (HF) with reduced ejection fraction. BACKGROUND: ... Full text Link to item Cite

Standardized Definitions for Evaluation of Heart Failure Therapies: Scientific Expert Panel From the Heart Failure Collaboratory and Academic Research Consortium.

Journal Article JACC Heart Fail · December 2020 The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory (HFC) and Academic Research Consortium (ARC), comprised of leading heart failure (HF) academic research investigators, patients, United States (US) Food ... Full text Link to item Cite

Conduct of Clinical Trials in the Era of COVID-19: JACC Scientific Expert Panel.

Journal Article J Am Coll Cardiol · November 17, 2020 The coronavirus disease-2019 (COVID-19) pandemic has profoundly changed clinical care and research, including the conduct of clinical trials, and the clinical research ecosystem will need to adapt to this transformed environment. The Heart Failure Academic ... Full text Link to item Cite

Depression and heart failure: the lonely comorbidity.

Journal Article Eur J Heart Fail · November 2020 Depression is a frequent and debilitating comorbidity that affects heart failure (HF) patients. Up to 30% of HF patients suffer from depression and even more have depressive symptoms. Moreover, depression carries a risk for HF, especially in high-risk grou ... Full text Link to item Cite

A new strategy for the synthesis of 2-amino-4H-pyran derivatives in aqueous media using DABCO-Cucl complex as a novel and efficient catalyst

Journal Article Eurasian Chemical Communications · November 1, 2020 2-Amino-4H-pyran derivatives are reported to have a broad spectrum of biological and pharmacological activities. Some are endowed with anticoagulant, spasmolitic, diuretic, anticancer and antianaphylactin. On the other hand, some 2-amino-4H-pyrans also can ... Full text Cite

Challenges and Potential Improvements to Patient Access to Pharmaceuticals: Examples From Cardiology.

Journal Article Circulation · August 25, 2020 Patient access to a drug after US regulatory approval is controlled by complex interactions between governmental and third-party payers, pharmacy benefit managers, distributers, manufacturers, health systems, and pharmacies that together mediate the receip ... Full text Link to item Cite

Representation of Women Authors in International Heart Failure Guidelines and Contemporary Clinical Trials.

Journal Article Circ Heart Fail · August 2020 BACKGROUND: Gender disparities in authorship of heart failure (HF) guideline citations and clinical trials have not been examined. METHODS: We identified authors of publications referenced in Class I Recommendations in United States (n=173) and European (n ... Full text Link to item Cite

Assessment of Limitations to Optimization of Guideline-Directed Medical Therapy in Heart Failure From the GUIDE-IT Trial: A Secondary Analysis of a Randomized Clinical Trial.

Journal Article JAMA Cardiol · July 1, 2020 IMPORTANCE: Despite evidence that guideline-directed medical therapy (GDMT) improves outcomes in patients with heart failure (HF) and reduced ejection fraction, many patients are undertreated. The Guiding Evidence-Based Therapy Using Biomarker Intensified ... Full text Link to item Cite

Publication Rates of Heart Failure Clinical Trials Remain Low.

Journal Article J Am Coll Cardiol · June 30, 2020 BACKGROUND: Under-reporting of clinical trial results inhibits dissemination of knowledge, limits understanding of therapeutic interventions, and may ultimately harm patients. OBJECTIVES: This study examined the rates and predictors of heart failure clinic ... Full text Link to item Cite

Endpoints in Heart Failure Drug Development: History and Future.

Journal Article JACC Heart Fail · June 2020 Heart failure (HF) patients experience a high burden of symptoms and functional limitations, and morbidity and mortality remain high despite successful therapies. The majority of HF drugs in the United States are approved for reducing hospitalization and m ... Full text Link to item Cite

Natriuretic Peptides as Inclusion Criteria in Clinical Trials: A JACC: Heart Failure Position Paper.

Journal Article JACC Heart Fail · May 2020 This study investigated the use of natriuretic peptides as inclusion criteria and to develop recommendations regarding their use. B-type natriuretic peptide (BNP) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) are commonly used as inclusion crit ... Full text Link to item Cite

Sex Differences in Quality of Life and Clinical Outcomes in Patients With Advanced Heart Failure: Insights From the PAL-HF Trial.

Journal Article Circ Heart Fail · April 2020 BACKGROUND: Palliative care improves quality of life in patients with heart failure. Whether men and women with heart failure derive similar benefit from palliative care interventions remains unknown. METHODS: In a secondary analysis of the PAL-HF trial (P ... Full text Link to item Cite

The Hospital Readmissions Reduction Program: Nationwide Perspectives and Recommendations: A JACC: Heart Failure Position Paper.

Journal Article JACC Heart Fail · January 2020 The mandatory federal pay-for-performance Hospital Readmissions Reduction Program (HRRP) was created to decrease 30-day hospital readmissions by instituting accountability and stimulating quality care and coordination, particularly during care transitions. ... Full text Link to item Cite

Adjudication Of Cause-specific Endpoints In Heart Failure Trials

Conference JOURNAL OF CARDIAC FAILURE · 2020 Cite

Heart Failure End Points in Cardiovascular Outcome Trials of Sodium Glucose Cotransporter 2 Inhibitors in Patients With Type 2 Diabetes Mellitus: A Critical Evaluation of Clinical and Regulatory Issues.

Journal Article Circulation · December 17, 2019 Following regulatory guidance set forth in 2008 by the US Food and Drug Administration for new drugs for type 2 diabetes mellitus, many large randomized, controlled trials have been conducted with the primary goal of assessing the safety of antihyperglycem ... Full text Link to item Cite

Clinical Implications of the New York Heart Association Classification.

Journal Article J Am Heart Assoc · December 3, 2019 Background The New York Heart Association (NYHA) classification has served as a fundamental tool for risk stratification of heart failure (HF) and determines clinical trial eligibility and candidacy for drugs and devices. However, its ability to adequately ... Full text Link to item Cite

Design of a "Lean" Case Report Form for Heart Failure Therapeutic Development.

Journal Article JACC Heart Fail · November 2019 The development of treatments for heart failure (HF) is challenged by burdensome clinical trials. Reducing the need for extensive data collection and increasing opportunities for data compatibility between trials may improve efficiency and reduce resource ... Full text Link to item Cite

Natriuretic Peptide Response and Outcomes in Chronic Heart Failure With Reduced Ejection Fraction.

Journal Article J Am Coll Cardiol · September 3, 2019 BACKGROUND: The GUIDE-IT (GUIDing Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure) trial demonstrated that a strategy to "guide" application of guideline-directed medical therapy (GDMT) by reducing amino-terminal pro-B-type na ... Full text Link to item Cite

Clinical factors related to morbidity and mortality in high-risk heart failure patients: the GUIDE-IT predictive model and risk score.

Journal Article Eur J Heart Fail · June 2019 BACKGROUND: Most heart failure (HF) risk scores have been derived from cohorts of stable HF patients and may not incorporate up to date treatment regimens or deep phenotype characterization that change baseline risk over the short- and long-term follow-up ... Full text Link to item Cite

Heart Failure Site-Based Research in the United States: Results of the Heart Failure Society of America Research Network Survey.

Journal Article JACC Heart Fail · May 2019 OBJECTIVES: This study sought to determine clinician and scientist involvement in heart failure (HF) clinical research and to describe the challenges of conducting clinical trials in the United States. BACKGROUND: Improvements in the current capability, po ... Full text Link to item Cite

NT-proBNP Goal Achievement Is Associated With Significant Reverse Remodeling and Improved Clinical Outcomes in HFrEF.

Journal Article JACC Heart Fail · February 2019 OBJECTIVES: This study aims to assess the association between biomarker-guided therapy and left ventricular (LV) remodeling. BACKGROUND: In patients with heart failure with reduced ejection fraction (HFrEF), it is unclear if lowering natriuretic peptides r ... Full text Link to item Cite

Adaptive servo-ventilation reduces atrial fibrillation burden in patients with heart failure and sleep apnea.

Journal Article Heart Rhythm · January 2019 BACKGROUND: Patients with heart failure and sleep apnea are at increased risk for developing arrhythmias. Whether treatment of sleep apnea reduces arrhythmias is unknown. OBJECTIVE: The purpose of this study was to determine whether adaptive servo-ventilat ... Full text Link to item Cite

Economic and Quality-of-Life Outcomes of Natriuretic Peptide-Guided Therapy for Heart Failure.

Journal Article J Am Coll Cardiol · November 27, 2018 BACKGROUND: The GUIDE-IT (GUIDing Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure) trial prospectively compared the efficacy of an N-terminal pro-B-type natriuretic peptide (NT-proBNP)-guided heart failure treatment strategy ( ... Full text Link to item Cite

Worsening renal function during decongestion among patients hospitalized for heart failure: Findings from the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE) trial.

Journal Article Am Heart J · October 2018 INTRODUCTION: Worsening renal function (WRF) can occur throughout a hospitalization for acute heart failure (HF). However, decongestion can be measured in different ways and the prognostic implications of WRF in the setting of different measures of deconge ... Full text Link to item Cite

Antihyperglycemic Therapies to Treat Patients With Heart Failure and Diabetes Mellitus.

Journal Article JACC Heart Fail · October 2018 There is increasing recognition of the relationship between diabetes and heart failure (HF). Comorbid diabetes is associated with worse outcomes in patients with HF, and death from HF forms a large burden of mortality among patients with diabetes and ather ... Full text Link to item Cite

Enrollment of Older Patients, Women, and Racial and Ethnic Minorities in Contemporary Heart Failure Clinical Trials: A Systematic Review.

Journal Article JAMA Cardiol · October 1, 2018 IMPORTANCE: Despite the importance of age, sex, and race/ethnicity representativeness in clinical trials, limited data exist regarding the enrollment trends of these groups in contemporary heart failure (HF) trials. OBJECTIVE: To characterize the represent ... Full text Link to item Cite

Reassessing the Role of Surrogate End Points in Drug Development for Heart Failure.

Journal Article Circulation · September 4, 2018 With few notable exceptions, drug development for heart failure (HF) has become progressively more challenging, and there remain no definitively proven therapies for patients with acute HF or HF with preserved ejection fraction. Inspection of temporal tren ... Full text Link to item Cite

Heart Failure With Preserved Ejection Fraction Expert Panel Report: Current Controversies and Implications for Clinical Trials.

Journal Article JACC Heart Fail · August 2018 The number of persons with heart failure has continued to rise over the last several years. Approximately one-half of those living with heart failure have heart failure with preserved ejection fraction, but critical unsolved questions remain across the spe ... Full text Open Access Link to item Cite

Dose Response of β-Blockers in Adrenergic Receptor Polymorphism Genotypes.

Journal Article Circ Genom Precis Med · August 2018 Background In heart failure (HF) with reduced ejection fraction, 2 clinical trials, the BEST (β-Blocker Evaluation of Survival Trial) and HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training), have reported an effectiven ... Full text Link to item Cite

Heart Failure Society of America Research Network Survey

Conference Journal of Cardiac Failure · August 2018 Full text Cite

Treatment of sleep-disordered breathing in heart failure impacts cardiac remodeling: Insights from the CAT-HF Trial.

Journal Article Am Heart J · July 2018 BACKGROUND: Sleep-disordered breathing (SDB), including central and obstructive sleep apnea, is a marker of poor prognosis in heart failure (HF) and may worsen cardiac dysfunction over time. Treatment of SDB with adaptive servoventilation (ASV) may reverse ... Full text Link to item Cite

The role of angiotensin receptor-neprilysin inhibitors in cardiovascular disease-existing evidence, knowledge gaps, and future directions.

Journal Article Eur J Heart Fail · June 2018 Although traditional renin-angiotensin system antagonists including angiotensin-converting enzyme inhibitors and angiotensin receptor blockers have revolutionized the treatment of cardiovascular disease (CVD), the pivotal PARADIGM-HF trial demonstrated tha ... Full text Link to item Cite

Improving Heart Failure Therapeutics Development in the United States: The Heart Failure Collaboratory.

Journal Article J Am Coll Cardiol · January 30, 2018 The current heart failure clinical trial environment is strained by increasing complexity and cost, regulatory requirements, competing demands on stakeholders, implementation challenges, and decreasing patient and investigator participation. To begin the p ... Full text Link to item Cite

Utility of Growth Differentiation Factor-15, A Marker of Oxidative Stress and Inflammation, in Chronic Heart Failure: Insights From the HF-ACTION Study.

Journal Article JACC Heart Fail · October 2017 OBJECTIVES: This study sought to determine the relationship between growth differentiation factor (GDF)-15 and clinical outcomes in ambulatory patients with heart failure and reduced ejection fraction (HFrEF). BACKGROUND: The prognostic utility of GDF-15, ... Full text Link to item Cite

Effect of Natriuretic Peptide-Guided Therapy on Hospitalization or Cardiovascular Mortality in High-Risk Patients With Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial.

Journal Article JAMA · August 22, 2017 IMPORTANCE: The natriuretic peptides are biochemical markers of heart failure (HF) severity and predictors of adverse outcomes. Smaller studies have evaluated adjusting HF therapy based on natriuretic peptide levels ("guided therapy") with inconsistent res ... Full text Link to item Cite

Palliative Care in Heart Failure: The PAL-HF Randomized, Controlled Clinical Trial.

Journal Article J Am Coll Cardiol · July 18, 2017 BACKGROUND: Advanced heart failure (HF) is characterized by high morbidity and mortality. Conventional therapy may not sufficiently reduce patient suffering and maximize quality of life. OBJECTIVES: The authors investigated whether an interdisciplinary pal ... Full text Link to item Cite

Palliative Care in Heart Failure The PAL-HF Randomized, Controlled Clinical Trial

Journal Article JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY · July 18, 2017 Link to item Cite

Comparison of Clinical Characteristics and Outcomes of Patients With Versus Without Diabetes Mellitus and With Versus Without Angina Pectoris (from the Duke Databank for Cardiovascular Disease).

Journal Article Am J Cardiol · June 1, 2017 Angina pectoris (AP) has different prognostic implications in various populations. Patients with diabetes mellitus (DM) may experience neuropathy such that AP may not be perceived in the setting of coronary artery disease (CAD). The prognostic utility of A ... Full text Link to item Cite

Exercise Training in Patients With Chronic Heart Failure and Atrial Fibrillation.

Journal Article J Am Coll Cardiol · April 4, 2017 BACKGROUND: The safety and efficacy of aerobic exercise in heart failure (HF) patients with atrial fibrillation (AF) has not been well evaluated. OBJECTIVES: This study examined whether outcomes with exercise training in HF vary according to AF status. MET ... Full text Link to item Cite

Cardiovascular Outcomes With Minute Ventilation-Targeted Adaptive Servo-Ventilation Therapy in Heart Failure: The CAT-HF Trial.

Journal Article J Am Coll Cardiol · March 28, 2017 BACKGROUND: Sleep apnea is common in hospitalized heart failure (HF) patients and is associated with increased morbidity and mortality. OBJECTIVES: The CAT-HF (Cardiovascular Improvements With MV-ASV Therapy in Heart Failure) trial investigated whether min ... Full text Link to item Cite

Efficacy and Safety of Tolvaptan in Patients Hospitalized With Acute Heart Failure.

Journal Article J Am Coll Cardiol · March 21, 2017 BACKGROUND: The oral vasopressin-2 receptor antagonist tolvaptan causes aquaresis in patients with volume overload, potentially facilitating decongestion and improving the clinical course of patients with acute heart failure (AHF). OBJECTIVES: The TACTICS- ... Full text Link to item Cite

Improving Medication Adherence in Cardiometabolic Disease: Practical and Regulatory Implications.

Journal Article Journal of the American College of Cardiology · January 2017 Medication nonadherence, a major problem in cardiovascular disease (CVD), contributes yearly to approximately 125,000 preventable deaths, which is partly attributable to only about one-half of CVD patients consistently taking prescribed life-saving medicat ... Full text Cite

A Multi-Marker Approach for Risk Stratification in Patients With Chronic Heart Failure: Insights From the HF-ACTION Trial

Conference · 2017 Introduction: It is unclear whether multi-marker approaches improve risk stratification among patients with heart failure (HF). We evaluated the prognostic utility of a multi-marker approach with biomarkers of HF status; Growth-differentiation factor-15 (G ... Cite

The US Food and Drug Administration and the Future of Cardiovascular Medicine.

Journal Article JAMA Cardiol · November 1, 2016 Cardiovascular medicine has led the drive for creativity and innovation with a culture that has been at the forefront of evidence generation. However, we are functioning at only a fraction of our evidence generation capacity. Despite the leadership of card ... Full text Link to item Cite

Relation of Angina Pectoris to Outcomes, Quality of Life, and Response to Exercise Training in Patients With Chronic Heart Failure (from HF-ACTION).

Journal Article Am J Cardiol · October 15, 2016 Angina pectoris (AP) is associated with worse outcomes in heart failure (HF). We investigated the association of AP with health-related quality of life (HRQoL), exercise capacity, and clinical outcomes and its interaction with exercise training in an HF po ... Full text Link to item Cite

Statins and Exercise Training Response in Heart Failure Patients: Insights From HF-ACTION.

Journal Article JACC Heart Fail · August 2016 OBJECTIVES: The aim of this study was to assess for a treatment interaction between statin use and exercise training (ET) response. BACKGROUND: Recent data suggest that statins may attenuate ET response, but limited data exist in patients with heart failur ... Full text Link to item Cite

Response to Exercise Training and Outcomes in Patients With Heart Failure and Diabetes Mellitus: Insights From the HF-ACTION Trial.

Journal Article J Card Fail · July 2016 BACKGROUND: In HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training), exercise training improved functional capacity in heart failure with reduced ejection fraction (HFrEF). Previous studies have suggested that diabetes ... Full text Link to item Cite

Abnormal liver function tests in acute heart failure: relationship with clinical characteristics and outcome in the PROTECT study.

Journal Article Eur J Heart Fail · July 2016 AIMS: Episodes of acute heart failure (AHF) unfavourably affect multiple organs, which may have an adverse impact on the outcomes. We investigated the prevalence and clinical consequences of abnormal liver function tests (LFTs) in AHF patients enrolled in ... Full text Link to item Cite

Are We Really in Love With Old Therapies?

Journal Article JACC Heart Fail · April 12, 2016 Full text Link to item Cite

Clinical predictors and outcomes of patients with left ventricular thrombus following ST-segment elevation myocardial infarction.

Journal Article J Thromb Thrombolysis · April 2016 We aimed to characterize the independent predictors of LVT following STEMI and the association with outcomes. The clinical predictors of left ventricular thrombus (LVT) formation after ST-segment elevation myocardial infarction (STEMI) are not well-defined ... Full text Link to item Cite

Lessons learned from a clinical trial: Design, rationale, and insights from The Cardiovascular Improvements with Minute Ventilation-targeted Adaptive Sero-Ventilation (ASV) Therapy in Heart Failure (CAT-HF) Study.

Journal Article Contemp Clin Trials · March 2016 OBJECTIVE: The CAT-HF Study was designed to evaluate the safety and efficacy of minute ventilation-targeted adaptive servo-ventilation (MV-ASV) during sleep in addition to optimized medical therapy (active therapy) versus optimized medical therapy alone (u ... Full text Link to item Cite

Heart Rate or Beta-Blocker Dose? Association With Outcomes in Ambulatory Heart Failure Patients With Systolic Dysfunction: Results From the HF-ACTION Trial.

Journal Article JACC Heart Fail · February 2016 OBJECTIVES: This study aimed to compare whether reduced heart rate (HR) or higher beta-blocker (BB) dose affected outcomes to a greater extent in the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) trial population ... Full text Link to item Cite

Prognostic Implications of Long-Chain Acylcarnitines in Heart Failure and Reversibility With Mechanical Circulatory Support.

Journal Article J Am Coll Cardiol · January 26, 2016 BACKGROUND: Heart failure (HF) is characterized by perturbations in energy homeostasis and metabolism. The reversibility and prognostic value of circulating markers associated with these changes remain unclear. OBJECTIVES: This study sought to describe the ... Full text Link to item Cite

Clinical Implications of Cluster Analysis-Based Classification of Acute Decompensated Heart Failure and Correlation with Bedside Hemodynamic Profiles.

Journal Article PLoS One · 2016 BACKGROUND: Classification of acute decompensated heart failure (ADHF) is based on subjective criteria that crudely capture disease heterogeneity. Improved phenotyping of the syndrome may help improve therapeutic strategies. OBJECTIVE: To derive cluster an ... Full text Link to item Cite

Cardiovascular Improvements With Adaptive Servo-Ventilation In Heart Failure: Insights From The Cat-Hf Trial

Conference AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE · January 1, 2016 Link to item Cite

Tolvaptan in Patients Hospitalized With Acute Heart Failure: Rationale and Design of the TACTICS and the SECRET of CHF Trials.

Journal Article Circ Heart Fail · September 2015 Congestion is a primary reason for hospitalization in patients with acute heart failure (AHF). Despite inpatient diuretics and vasodilators targeting decongestion, persistent congestion is present in many AHF patients at discharge and more severe congestio ... Full text Link to item Cite

Comparative effectiveness of torsemide versus furosemide in heart failure patients: insights from the PROTECT trial.

Journal Article Future Cardiol · September 2015 AIM: The authors assessed the comparative effectiveness of torsemide versus furosemide in the PROTECT trial. METHODS: The authors assessed the relationship between loop diuretic at discharge and death or cardiovascular/renal hospitalization within 30 days, ... Full text Link to item Cite

Site selection for heart failure clinical trials in the USA.

Journal Article Heart Fail Rev · July 2015 There are more than 1 million primary hospitalizations for heart failure (HF) annually in the USA alone, and post-discharge outcomes remain persistently poor despite available therapies and quality improvement initiatives. Recent international randomized c ... Full text Link to item Cite

Evaluation of the Incremental Prognostic Utility of Increasingly Complex Testing in Chronic Heart Failure.

Journal Article Circ Heart Fail · July 2015 BACKGROUND: Current heart failure (HF) risk prediction models do not consider how individual patient assessments occur in incremental steps; furthermore, each additional diagnostic evaluation may add cost, complexity, and potential morbidity. METHODS AND R ... Full text Link to item Cite

Early vs. late worsening heart failure during acute heart failure hospitalization: insights from the PROTECT trial.

Journal Article Eur J Heart Fail · July 2015 BACKGROUND: Worsening heart failure (WHF) symptoms despite initial therapy during admission for acute heart failure (AHF) is associated with worse outcomes. The association between the time of the WHF event and the intensity of WHF therapy with outcomes is ... Full text Link to item Cite

Torsemide versus furosemide in heart failure patients: insights from Duke University Hospital.

Journal Article J Cardiovasc Pharmacol · May 2015 Furosemide has historically been the primary loop diuretic in heart failure patients despite data suggesting potential advantages with torsemide. We used the Duke Echocardiography Lab Database to investigate patients admitted with heart failure to Duke Hos ... Full text Open Access Link to item Cite

Patient selection in heart failure with preserved ejection fraction clinical trials.

Journal Article J Am Coll Cardiol · April 28, 2015 Recent clinical trials in patients with heart failure with preserved ejection fraction (HFpEF) have provided important insights into participant selection strategies. Historically, HFpEF trials have included patients with relatively preserved left ventricu ... Full text Link to item Cite

Improving cardiovascular clinical trials conduct in the United States: recommendation from clinicians, researchers, sponsors, and regulators.

Journal Article Am Heart J · March 2015 Advances in medical therapies leading to improved patient outcomes are in large part related to successful conduct of clinical trials that offer critical information regarding the efficacy and safety of novel interventions. The conduct of clinical trials i ... Full text Link to item Cite

Galectin-3 and mineralocorticoid receptor antagonist use in patients with chronic heart failure due to left ventricular systolic dysfunction.

Journal Article Am Heart J · March 2015 BACKGROUND: Galectin-3 is a prognostic heart failure biomarker associated with aldosterone-induced myocardial fibrosis; mineralocorticoid receptor antagonists (MRAs) may reduce such fibrosis. We sought to examine outcomes of patients with heart failure wit ... Full text Link to item Cite

Acute heart failure in elderly patients: worse outcomes and differential utility of standard prognostic variables. Insights from the PROTECT trial.

Journal Article Eur J Heart Fail · January 2015 AIMS: Previous heart failure (HF) trials suggested that age influences patient characteristics and outcome; however, under-representation of elderly patients has limited characterization of this cohort. Whether standard prognostic variables have differenti ... Full text Link to item Cite

Ischaemia change with revascularisation versus medical therapy in reduced ejection fraction.

Journal Article Open Heart · 2015 OBJECTIVE: Nuclear imaging data demonstrate that revascularisation leads to favourable effects on ischaemia burden and improved outcomes compared with medical therapy (MT). In patients with heart failure (HF), the effects of MT versus revascularisation on ... Full text Open Access Link to item Cite

Noncardiac comorbidities in heart failure with reduced versus preserved ejection fraction.

Journal Article J Am Coll Cardiol · December 2, 2014 Heart failure patients are classified by ejection fraction (EF) into distinct groups: heart failure with preserved ejection fraction (HFpEF) or heart failure with reduced ejection fraction (HFrEF). Although patients with heart failure commonly have multipl ... Full text Link to item Cite

Race, common genetic variation, and therapeutic response disparities in heart failure.

Journal Article JACC Heart Fail · December 2014 Because of its comparatively recent evolution, Homo sapiens exhibit relatively little within-species genomic diversity. However, because of genome size, a proportionately small amount of variation creates ample opportunities for both rare mutations that ma ... Full text Link to item Cite

The palliative care in heart failure trial: rationale and design.

Journal Article Am Heart J · November 2014 BACKGROUND: The progressive nature of heart failure (HF) coupled with high mortality and poor quality of life mandates greater attention to palliative care as a routine component of advanced HF management. Limited evidence exists from randomized, controlle ... Full text Link to item Cite

Charting a roadmap for heart failure biomarker studies.

Journal Article JACC Heart Fail · October 2014 Heart failure is a syndrome with a pathophysiological basis that can be traced to dysfunction in several interconnected molecular pathways. Identification of biomarkers of heart failure that allow measurement of the disease on a molecular level has resulte ... Full text Link to item Cite

Potential applications of pharmacogenomics to heart failure therapies.

Journal Article Heart Fail Clin · October 2014 Pharmacogenomics explores one drug's varying effects on different patient genotypes. A better understanding of genomic variation's contribution to drug response can impact 4 arenas in heart failure (HF): (1) identification of patients most likely to receiv ... Full text Link to item Cite

Rationale and design of the GUIDE-IT study: Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.

Journal Article JACC Heart Fail · October 2014 OBJECTIVES: The GUIDE-IT (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure) study is designed to determine the safety, efficacy, and cost-effectiveness of a strategy of adjusting therapy with the goal of achieving and m ... Full text Link to item Cite

Persistent angina pectoris in ischaemic cardiomyopathy: increased rehospitalization and major adverse cardiac events.

Journal Article Eur J Heart Fail · August 2014 AIMS: The impact of refractory angina pectoris (AP) in patients with ischaemic cardiomyopathy (ICM) is unknown. We investigated the characteristics and outcomes of ICM patients with persistent AP following cardiac catheterization. METHODS AND RESULTS: Pati ... Full text Link to item Cite

International differences in clinical characteristics, management, and outcomes in acute heart failure patients: better short-term outcomes in patients enrolled in Eastern Europe and Russia in the PROTECT trial.

Journal Article Eur J Heart Fail · June 2014 AIMS: The implications of geographical variation are unknown following adjustment for hospital length of stay (LOS) in heart failure (HF) trials that included patients whether or not they had systolic dysfunction. We investigated regional differences in an ... Full text Link to item Cite

Biomarkers of myocardial stress and fibrosis as predictors of mode of death in patients with chronic heart failure.

Journal Article JACC Heart Fail · June 2014 OBJECTIVES: The aim of this study was to determine whether biomarkers of myocardial stress and fibrosis improve prediction of the mode of death in patients with chronic heart failure. BACKGROUND: The 2 most common modes of death in patients with chronic he ... Full text Link to item Cite

Diuretic response in acute heart failure: clinical characteristics and prognostic significance.

Conference Eur Heart J · May 14, 2014 AIM: Diminished diuretic response is common in patients with acute heart failure, although a clinically useful definition is lacking. Our aim was to investigate a practical, workable metric for diuretic response, examine associated patient characteristics ... Full text Link to item Cite

Decongestion in acute heart failure.

Journal Article Eur J Heart Fail · May 2014 Congestion is a major reason for hospitalization in acute heart failure (HF). Therapeutic strategies to manage congestion include diuretics, vasodilators, ultrafiltration, vasopressin antagonists, mineralocorticoid receptor antagonists, and potentially als ... Full text Link to item Cite

Sleep-disordered breathing in patients with heart failure.

Journal Article Heart Fail Clin · April 2014 Sleep-disordered breathing (SDB) is prevalent in patients with heart failure, and is associated with increased morbidity and mortality. SDB is proinflammatory, with nocturnal oxygen desaturations and hypercapnia appearing to play a pivotal role in the deve ... Full text Link to item Cite

SOCIOECONOMIC STATUS, MARITAL STATUS AND OUTCOMES IN HEART FAILURE: FINDINGS FROM HF-ACTION

Conference Journal of the American College of Cardiology · April 2014 Full text Cite

The effects of exercise on cardiovascular biomarkers in patients with chronic heart failure.

Journal Article Am Heart J · February 2014 BACKGROUND: Exercise training is recommended for chronic heart failure (HF) patients to improve functional status and reduce risk of adverse outcomes. Elevated plasma levels of amino-terminal pro-brain natriuretic peptide (NT-proBNP), high-sensitivity C-re ... Full text Link to item Cite

Heart failure with preserved ejection fraction: comparison of patients with and without angina pectoris (from the Duke Databank for Cardiovascular Disease).

Journal Article J Am Coll Cardiol · January 28, 2014 OBJECTIVES: This study investigated the characteristics and outcomes of patients with heart failure with preserved ejection fraction (HFpEF) and angina pectoris (AP). BACKGROUND: AP is a predictor of adverse events in patients with heart failure with reduc ... Full text Link to item Cite

Predictors of postdischarge outcomes from information acquired shortly after admission for acute heart failure: a report from the Placebo-Controlled Randomized Study of the Selective A1 Adenosine Receptor Antagonist Rolofylline for Patients Hospitalized With Acute Decompensated Heart Failure and Volume Overload to Assess Treatment Effect on Congestion and Renal Function (PROTECT) Study.

Journal Article Circ Heart Fail · January 2014 BACKGROUND: Acute heart failure is a common reason for admission, and outcome is often poor. Improved prognostic risk stratification may assist in the design of future trials and in patient management. Using data from a large randomized trial, we explored ... Full text Link to item Cite

Relationship between galectin-3 levels and mineralocorticoid receptor antagonist use in heart failure: analysis from HF-ACTION.

Journal Article J Card Fail · January 2014 BACKGROUND: Galectin-3 (Gal-3) is a marker of myocardial fibrosis, and elevated levels are associated with adverse outcomes. Mineralocorticoid receptor antagonists (MRAs) modulate cardiac fibrosis in heart failure (HF) patients and have been shown to impro ... Full text Link to item Cite

Heart rate: a prognostic factor and therapeutic target in chronic heart failure. The distinct roles of drugs with heart rate-lowering properties.

Journal Article Eur J Heart Fail · January 2014 Heart rate not only predicts outcome but may also be a therapeutic target in patients with chronic heart failure. Several classes of pharmacological agents can be used to modulate heart rate, including beta-blockers, ivabradine, digoxin, amiodarone, and ve ... Full text Link to item Cite

Sex-specific acute heart failure phenotypes and outcomes from PROTECT.

Journal Article Eur J Heart Fail · December 2013 AIMS: Differences in manifestation, treatment, and outcomes of acute heart failure between men and women have not been well studied. The objective of this analysis was to characterize differences in clinical presentation, and in-hospital and post-discharge ... Full text Link to item Cite

Soluble ST2 in ambulatory patients with heart failure: Association with functional capacity and long-term outcomes.

Journal Article Circ Heart Fail · November 2013 BACKGROUND: ST2 is involved in cardioprotective signaling in the myocardium and has been identified as a potentially promising biomarker in heart failure (HF). We evaluated ST2 levels and their association with functional capacity and long-term clinical ou ... Full text Link to item Cite

Learning from recent trials and shaping the future of acute heart failure trials.

Journal Article Am Heart J · October 2013 The last decade of acute heart failure (HF) research is characterized by disappointments in large phase 2 and 3 pharmacologic studies of therapeutics including calcium-sensitizing agents and antagonists of endothelin, vasopressin, and adenosine. As a resul ... Full text Link to item Cite

The past, present and future of renin-angiotensin aldosterone system inhibition.

Journal Article Int J Cardiol · September 1, 2013 The renin-angiotensin aldosterone system (RAAS) is central to the pathogenesis of cardiovascular disease. RAAS inhibition can reduce blood pressure, prevent target organ damage in hypertension and diabetes, and improve outcomes in patients with heart failu ... Full text Link to item Cite

Prevention of atrial fibrillation by bucindolol is dependent on the beta₁389 Arg/Gly adrenergic receptor polymorphism.

Journal Article JACC Heart Fail · August 2013 OBJECTIVES: This study assessed the impact of bucindolol, a beta-blocker/sympatholytic agent, on the development of atrial fibrillation (AF) in advanced chronic heart failure with reduced left ventricular ejection fraction (HFREF) patients enrolled in the ... Full text Link to item Cite

Biomarker-guided therapies in heart failure: a forum for unified strategies.

Journal Article J Card Fail · August 2013 The complexity of standard medical treatment for heart failure is growing, and such therapy typically involves 5 or more different medications. Given these pressures, there is increasing interest in harnessing cardiovascular biomarkers for clinical applica ... Full text Link to item Cite

Heart failure in elderly patients: distinctive features and unresolved issues.

Journal Article Eur J Heart Fail · July 2013 The prevalence of heart failure (HF) increases with age. While clinical trials suggest that contemporary evidence-based HF therapies have reduced morbidity and mortality, these trials largely excluded the elderly. Questions remain regarding the clinical ch ... Full text Link to item Cite

Association between adrenergic receptor genotypes and beta-blocker dose in heart failure patients: analysis from the HF-ACTION DNA substudy.

Journal Article Eur J Heart Fail · March 2013 AIMS: Beta-blockers reduce morbidity and mortality in chronic heart failure (HF) patients with reduced ejection fraction. However, there is heterogeneity in the response to these drugs, perhaps due to genetic variations in the β1-adrenergic receptor (ADRβ1 ... Full text Link to item Cite

Effect of bucindolol on heart failure outcomes and heart rate response in patients with reduced ejection fraction heart failure and atrial fibrillation.

Journal Article Eur J Heart Fail · March 2013 AIMS: There is little evidence of beta-blocker treatment benefit in patients with heart failure and reduced left ventricular ejection fraction (HFREF) and atrial fibrillation (AF). We investigated the effects of bucindolol in HFREF patients with AF enrolle ... Full text Link to item Cite

Association of beta-blocker use and selectivity with outcomes in patients with heart failure and chronic obstructive pulmonary disease (from OPTIMIZE-HF).

Journal Article Am J Cardiol · February 15, 2013 In patients with heart failure (HF) with chronic obstructive pulmonary disease (COPD), concerns exist regarding β blockers, particularly noncardioselective β blockers, precipitating bronchospasm or attenuating the benefit of inhaled β(2) agonists. The aim ... Full text Link to item Cite

Clinical characteristics, response to exercise training, and outcomes in patients with heart failure and chronic obstructive pulmonary disease: findings from Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing (HF-ACTION).

Journal Article Am Heart J · February 2013 BACKGROUND: The aim of this study was to investigate the clinical characteristics, exercise training response, β-blocker selectivity, and outcomes in patients with heart failure (HF) and chronic obstructive pulmonary disease (COPD). METHODS: We performed a ... Full text Link to item Cite

Health status and depression remission in patients with chronic heart failure: patient-reported outcomes from the SADHART-CHF trial.

Journal Article Circ Heart Fail · November 2012 BACKGROUND: Depression is a common comorbidity in heart failure and is strongly associated with increased mortality, morbidity, and reduced health status. Whether depression treatment may result in improvement of health status in heart failure patients wit ... Full text Link to item Cite

Implications of geographical variation on clinical outcomes of cardiovascular trials.

Journal Article Am Heart J · September 2012 Cardiovascular clinical trials are increasingly conducted globally as a means to reduce costs, expedite timelines, provide broad applicability, and satisfy regulatory authorities. Potential problems with trial globalization include regional differences in ... Full text Link to item Cite

Relationship of beta-blocker dose with outcomes in ambulatory heart failure patients with systolic dysfunction: results from the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) trial.

Journal Article J Am Coll Cardiol · July 17, 2012 OBJECTIVES: This study sought to examine the association between baseline beta-blocker (BB) dose and outcomes in the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) trial. BACKGROUND: Beta-blockers reduce morbidity ... Full text Link to item Cite

Ischemia change in stable coronary artery disease is an independent predictor of death and myocardial infarction.

Journal Article JACC Cardiovasc Imaging · July 2012 OBJECTIVES: The aim of this study was to evaluate the independent prognostic significance of ischemia change in stable coronary artery disease (CAD). BACKGROUND: Recent randomized trials in stable CAD have suggested that revascularization does not improve ... Full text Link to item Cite

The PROTECT in-hospital risk model: 7-day outcome in patients hospitalized with acute heart failure and renal dysfunction.

Journal Article Eur J Heart Fail · June 2012 AIMS: In patients with acute heart failure (AHF), early worsening heart failure (WHF) predicts a significant proportion of post-discharge readmissions and mortality. We aimed to identify the predictors of 7-day heart failure events or death in patients hos ... Full text Link to item Cite

Bronchodilators in heart failure patients with COPD: is it time for a clinical trial?

Journal Article J Card Fail · May 2012 Chronic heart failure (HF) and chronic obstructive pulmonary disease (COPD) commonly coexist, and patients with both diseases fare worse than those with either disease alone. Several factors may contribute to worse outcomes, including an increased burden o ... Full text Link to item Cite

Comparison of Clinical characteristics and long-term outcomes of patients with ischemic cardiomyopathy with versus without angina pectoris (from the Duke Databank for Cardiovascular Disease).

Journal Article Am J Cardiol · May 1, 2012 Myocardial ischemic origin is a significant independent predictor of mortality in patients with heart failure (HF). The implications of angina pectoris (AP) in HF are less well characterized. The aim of this study was to compare the clinical characteristic ... Full text Link to item Cite

Clinical characteristics and outcomes of hospitalized heart failure patients with systolic dysfunction and chronic obstructive pulmonary disease: findings from OPTIMIZE-HF.

Journal Article Eur J Heart Fail · April 2012 AIMS: Chronic obstructive pulmonary disease (COPD) is common in heart failure (HF) patients, yet the population is poorly characterized and associated with conflicting outcomes data. We aimed to evaluate the clinical characteristics and outcomes of HF pati ... Full text Link to item Cite

Novel biomarkers in chronic heart failure.

Journal Article Nat Rev Cardiol · March 27, 2012 Understanding of chronic heart failure (HF) has progressed from a syndrome of disordered hemodynamics caused by alterations in the structure of the heart to one that involves intertwined molecular pathways in disarray. Accordingly, the assessment and treat ... Full text Link to item Cite

QUALITY OF LIFE 60 DAYS AFTER AN ACUTE HEART FAILURE EVENT: INSIGHTS FROM THE PROTECT TRIAL

Conference Journal of the American College of Cardiology · March 2012 Full text Cite

Plasma omega-3 polyunsaturated fatty acids and survival in patients with chronic heart failure and major depressive disorder.

Journal Article J Cardiovasc Transl Res · February 2012 The omega-3 fatty acid (FA) concentration is low in patients with coronary heart disease (CHD). Supplement of omega-3 FA improves cardiovascular outcomes in patients with CHD and heart failure (HF). However, plasma omega-3 FA and its role for prognosis in ... Full text Link to item Cite

Significance of hyponatremia in heart failure.

Journal Article Heart Fail Rev · January 2012 Heart failure is one of the most common, costly, disabling and growing diseases (McMurray and Pfeffer in Lancet 365(9474):1877-1889, 2005). Hyponatremia, conventionally defined as a serum-sodium concentration equal or less than 135 mmol/l (American Heart A ... Full text Link to item Cite

Combinatorial pharmacogenetic interactions of bucindolol and β1, α2C adrenergic receptor polymorphisms.

Journal Article PLoS One · 2012 BACKGROUND: Pharmacogenetics involves complex interactions of gene products affecting pharmacodynamics and pharmacokinetics, but there is little information on the interaction of multiple genetic modifiers of drug response. Bucindolol is a β-blocker/sympat ... Full text Link to item Cite

Factors related to morbidity and mortality in patients with chronic heart failure with systolic dysfunction: the HF-ACTION predictive risk score model.

Journal Article Circ Heart Fail · January 2012 BACKGROUND: We aimed to develop a multivariable statistical model for risk stratification in patients with chronic heart failure with systolic dysfunction, using patient data that are routinely collected and easily obtained at the time of initial presentat ... Full text Link to item Cite

Galectin-3 in ambulatory patients with heart failure: results from the HF-ACTION study.

Journal Article Circ Heart Fail · January 2012 BACKGROUND: Galectin-3 is a soluble ß-galactoside-binding lectin released by activated cardiac macrophages. Elevated levels of galectin-3 have been found to be associated with adverse outcomes in patients with heart failure. We evaluated the association be ... Full text Link to item Cite

Hyponatremia and long-term outcomes in chronic heart failure--an observational study from the Duke Databank for Cardiovascular Diseases.

Journal Article J Card Fail · January 2012 BACKGROUND: Hyponatremia is a well known predictor of short-term outcomes in heart failure (HF); however, its impact on long-term survival in HF patients with systolic dysfunction is not well established. METHODS AND RESULTS: Using the Duke Databank for Ca ... Full text Link to item Cite

Link between decisions regarding resuscitation and preferences for quality over length of life with heart failure.

Journal Article Eur J Heart Fail · January 2012 AIMS: Survival preferences, ascertained from time-trade-off utilities, have not been studied in heart failure patients who designate a 'do not resuscitate' (DNR) status. Therefore, the aim of this study was to determine the association of heart failure pat ... Full text Link to item Cite

Mode of death and hospitalization from the Second Follow-up Serial Infusions of Nesiritide (FUSION II) trial and comparison of clinical events committee adjudicated versus investigator reported outcomes.

Journal Article Am J Cardiol · November 15, 2011 The aim of this study was to evaluate the mode of death and hospitalizations in advanced heart failure (HF) patients with renal dysfunction and to examine the rate of concordance between events reported by the clinical events committee and site investigato ... Full text Link to item Cite

Impact of serial troponin release on outcomes in patients with acute heart failure: analysis from the PROTECT pilot study.

Journal Article Circ Heart Fail · November 2011 BACKGROUND: Cardiac troponin T (cTnT) elevation is common and is a predictor of outcomes in patients with acute heart failure (AHF). The degree and progression of cTnT release during hospitalization of patients with AHF is unclear. We evaluated the inciden ... Full text Link to item Cite

Lessons learned from clinical trials in acute heart failure: phase 3 drug trials.

Journal Article Heart Fail Clin · October 2011 Phase 3 clinical trials in acute heart failure are conducted to allow safety and efficacy data to be collected for the evaluation of treatment strategies, including drugs, devices, diagnostics, or nonpharmacological interventions. There are several importa ... Full text Link to item Cite

Conduct of clinical trials in acute heart failure: regional differences in heart failure clinical trials.

Journal Article Heart Fail Clin · October 2011 Clinical trials are often conducted globally. Differences in standard of care, patient populations including genetic and phenotypic differences, disease etiologies, rates of comorbidities, ascertainment of endpoints, and differences in concomitant therapie ... Full text Link to item Cite

Pharmacogenetics in heart failure trials.

Journal Article Heart Fail Clin · October 2011 There is ongoing research into potential pharmacogenetic targets in heart failure. Several challenges exist despite the potential benefits, and questions remain on the level of evidence needed to support product approval or labeling. High annual mortality, ... Full text Link to item Cite

Influence of global region on outcomes in heart failure β-blocker trials.

Journal Article J Am Coll Cardiol · August 23, 2011 OBJECTIVES: We sought to describe the United States and the rest of the world (ROW) outcomes from the major β-blocker heart failure (HF) trials. BACKGROUND: HF trials have demonstrated differences in outcomes by geographic region. METHODS: Randomized, doub ... Full text Link to item Cite

The STARBRITE trial: a randomized, pilot study of B-type natriuretic peptide-guided therapy in patients with advanced heart failure.

Journal Article J Card Fail · August 2011 BACKGROUND: STARBRITE, a multicenter randomized pilot trial, tested whether outpatient diuretic management guided by B-type natriuretic peptide (BNP) and clinical assessment resulted in more days alive and not hospitalized over 90 days compared with clinic ... Full text Link to item Cite

Bucindolol: new hopes from reviewing past data.

Journal Article Drugs Today (Barc) · May 2011 β-Adrenoceptor antagonists or β-blockers are a cornerstone of therapy in chronic heart failure (CHF). Bucindolol hydrochloride is a fourth-generation β-blocker in development for the treatment of CHF. Two trials have been conducted to evaluate its use in C ... Full text Link to item Cite

HYPONATREMIA AND LONG-TERM OUTCOMES IN HEART FAILURE

Conference Journal of the American College of Cardiology · April 2011 Full text Cite

Clinical development of pharmacologic agents for acute heart failure syndromes: a proposal for a mechanistic translational phase.

Journal Article Am Heart J · February 2011 Hospitalization for acute heart failure syndromes (AHFS) predicts a poor prognosis, with postdischarge mortality and rehospitalization rates reaching 45% within 60 to 90 days. Despite the use of evidence-based therapies and adherence to national process me ... Full text Link to item Cite

United States stock market performance and acute myocardial infarction rates in 2008-2009 (from the Duke Databank for Cardiovascular Disease).

Journal Article Am J Cardiol · December 1, 2010 We sought to examine the relation between the United States economic decrease in 2008 and cardiovascular events as measured by local acute myocardial infarction (AMI) rates. Mental stress and traumatic events have been shown to be associated with increased ... Full text Link to item Cite

Dronedarone and vitamin K antagonists: a review of drug-drug interactions.

Journal Article Am Heart J · October 2010 Adverse drug events affect millions of patients each year. An important drug-drug interaction between amiodarone and vitamin K antagonists is encountered frequently in daily clinical practice. Warfarin, a commonly used anticoagulant, is a mixture of 2 opti ... Full text Link to item Cite

Determination of hospitalization type by investigator case report form or adjudication committee in a large heart failure clinical trial (β-Blocker Evaluation of Survival Trial [BEST]).

Journal Article Am Heart J · October 2010 BACKGROUND: End point committees are routinely used to adjudicate efficacy and safety end points in clinical trials. The 2,708-patient β-Blocker Evaluation of Survival Trial (BEST) originally determined hospitalization type via investigator case report for ... Full text Link to item Cite

Triage after hospitalization with advanced heart failure: the ESCAPE (Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness) risk model and discharge score.

Journal Article J Am Coll Cardiol · March 2, 2010 OBJECTIVES: Identifying high-risk heart failure (HF) patients at hospital discharge may allow more effective triage to management strategies. BACKGROUND: Heart failure severity at presentation predicts outcomes, but the prognostic importance of clinical st ... Full text Link to item Cite

HAS THE US STOCK MARKET COLLAPSE IMPACTED CARDIOVASCULAR EVENT RATES?

Conference JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY · 2010 Cite

IMPACT OF BASELINE VOLUME STATUS AND LVEF ON ALL-CAUSE MORTALITY IN THE BEST TRIAL

Conference JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY · 2010 Cite

Targeting heart failure therapeutics: a historical perspective.

Journal Article Heart Fail Clin · January 2010 This article reviews information on the role of genetic variability in the development, progression, and treatment of heart failure. It focuses primarily on genetic variation in neurohormonal systems, where adrenergic receptors and the renin-angiotensin-al ... Full text Link to item Cite

Marital Status and Prognosis of Patients with Heart Failure

Journal Article Journal of Cardiac Failure · August 2009 Full text Cite

Using genetic information to select treatment for patients with heart failure: has the time come?

Journal Article Per Med · July 2009 Personalized medicine is the concept of patient care becoming individualized based on distinctive characteristics. Pharmacogenetics is an application of personalized medicine, which may allow us to predict response to treatment based on an individual's gen ... Full text Link to item Cite

Outcomes of a consult fall prevention screening clinic.

Journal Article Am J Phys Med Rehabil · November 2006 OBJECTIVE: To report patient satisfaction and quality outcomes from a standardized, multicenter fall prevention screening clinic. DESIGN: Referrals were made to the fall prevention screening clinic, which was staffed by a physician, pharmacist, therapist, ... Full text Link to item Cite

Histamine-2 (H2) receptor antagonists may not necessarily cross-react to induce thrombocytopenia

Journal Article Journal of Pharmacy Practice · January 1, 1998 Drug-induced thrombocytopenia has been reported with cimetidine, ranitidine, and famotidine. The mechanism for this rare adverse event remains unclear despite several suggested explanations. Cross-reactivity between the H2 receptor antagonists h ... Full text Cite