Standardized definitions for evaluation of heart failure therapies: scientific expert panel from the Heart Failure Collaboratory and Academic Research Consortium.
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 and Drug Administration representatives, and industry members from the US and Europe. A series of meetings were convened to establish definitions and key concepts for the evaluation of HF therapies including optimal medical and device background therapy, clinical trial design elements and statistical concepts, and study endpoints. This manuscript summarizes the expert panel discussions as consensus recommendations focused on populations and endpoint definitions; it is not exhaustive or restrictive, but designed to stimulate HF clinical trial innovation.
Duke Scholars
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Related Subject Headings
- United States
- Treatment Outcome
- Terminology as Topic
- Quality of Life
- Patient Reported Outcome Measures
- Humans
- Hospitalization
- Heart Failure
- Europe
- Endpoint Determination
Citation
Published In
DOI
EISSN
Publication Date
Volume
Issue
Start / End Page
Location
Related Subject Headings
- United States
- Treatment Outcome
- Terminology as Topic
- Quality of Life
- Patient Reported Outcome Measures
- Humans
- Hospitalization
- Heart Failure
- Europe
- Endpoint Determination