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Efficacy and safety of dapagliflozin in acute heart failure: Rationale and design of the DICTATE-AHF trial.

Publication ,  Journal Article
Cox, ZL; Collins, SP; Aaron, M; Hernandez, GA; Iii, ATM; Davidson, BT; Fowler, M; Lindsell, CJ; Jr, FEH; Jenkins, CA; Kampe, C; Miller, KF ...
Published in: Am Heart J
February 2021

BACKGROUND: Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, reduces cardiovascular death and worsening heart failure in patients with chronic heart failure and reduced ejection fraction. Early initiation during an acute heart failure (AHF) hospitalization may facilitate decongestion, improve natriuresis, and facilitate safe transition to a beneficial outpatient therapy for both diabetes and heart failure. OBJECTIVE: The objective is to assess the efficacy and safety of initiating dapagliflozin within the first 24 hours of hospitalization in patients with AHF compared to usual care. METHODS: DICTATE-AHF is a prospective, multicenter, open-label, randomized trial enrolling a planned 240 patients in the United States. Patients with type 2 diabetes hospitalized with hypervolemic AHF and an estimated glomerular filtration rate of at least 30 mL/min/1.73m2 are eligible for participation. Patients are randomly assigned 1:1 to dapagliflozin 10 mg once daily or structured usual care until day 5 or hospital discharge. Both treatment arms receive protocolized diuretic and insulin therapies. The primary endpoint is diuretic response expressed as the cumulative change in weight per cumulative loop diuretic dose in 40 mg intravenous furosemide equivalents. Secondary and exploratory endpoints include inpatient worsening AHF, 30-day hospital readmission for AHF or diabetic reasons, change in NT-proBNP, and measures of natriuresis. Safety endpoints include the incidence of hyper/hypoglycemia, ketoacidosis, worsening kidney function, hypovolemic hypotension, and inpatient mortality. CONCLUSIONS: The DICTATE-AHF trial will establish the efficacy and safety of early initiation of dapagliflozin during AHF across both AHF and diabetic outcomes in patients with diabetes.

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Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

February 2021

Volume

232

Start / End Page

116 / 124

Location

United States

Related Subject Headings

  • Weight Loss
  • Treatment Outcome
  • Sodium-Glucose Transporter 2 Inhibitors
  • Sodium Potassium Chloride Symporter Inhibitors
  • Renal Insufficiency, Chronic
  • Randomized Controlled Trials as Topic
  • Peptide Fragments
  • Patient Readmission
  • Natriuretic Peptide, Brain
  • Natriuresis
 

Citation

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Cox, Z. L., Collins, S. P., Aaron, M., Hernandez, G. A., Iii, A. T. M., Davidson, B. T., … Lindenfeld, J. (2021). Efficacy and safety of dapagliflozin in acute heart failure: Rationale and design of the DICTATE-AHF trial. Am Heart J, 232, 116–124. https://doi.org/10.1016/j.ahj.2020.10.071
Cox, Zachary L., Sean P. Collins, Mark Aaron, Gabriel A. Hernandez, A Thomas McRae Iii, Beth T. Davidson, Mike Fowler, et al. “Efficacy and safety of dapagliflozin in acute heart failure: Rationale and design of the DICTATE-AHF trial.Am Heart J 232 (February 2021): 116–24. https://doi.org/10.1016/j.ahj.2020.10.071.
Cox ZL, Collins SP, Aaron M, Hernandez GA, Iii ATM, Davidson BT, et al. Efficacy and safety of dapagliflozin in acute heart failure: Rationale and design of the DICTATE-AHF trial. Am Heart J. 2021 Feb;232:116–24.
Cox, Zachary L., et al. “Efficacy and safety of dapagliflozin in acute heart failure: Rationale and design of the DICTATE-AHF trial.Am Heart J, vol. 232, Feb. 2021, pp. 116–24. Pubmed, doi:10.1016/j.ahj.2020.10.071.
Cox ZL, Collins SP, Aaron M, Hernandez GA, Iii ATM, Davidson BT, Fowler M, Lindsell CJ, Jr FEH, Jenkins CA, Kampe C, Miller KF, Stubblefield WB, Lindenfeld J. Efficacy and safety of dapagliflozin in acute heart failure: Rationale and design of the DICTATE-AHF trial. Am Heart J. 2021 Feb;232:116–124.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

February 2021

Volume

232

Start / End Page

116 / 124

Location

United States

Related Subject Headings

  • Weight Loss
  • Treatment Outcome
  • Sodium-Glucose Transporter 2 Inhibitors
  • Sodium Potassium Chloride Symporter Inhibitors
  • Renal Insufficiency, Chronic
  • Randomized Controlled Trials as Topic
  • Peptide Fragments
  • Patient Readmission
  • Natriuretic Peptide, Brain
  • Natriuresis