African-American Heart Failure Trial (A-HeFT): Rationale, design, and methodology

Joseph A. Franciosa*, Anne L. Taylor, Jay N. Cohn, Clyde W. Yancy, Susan Ziesche, Adeoye Olukotun, Elizabeth Ofili, Keith Ferdinand, Joseph Loscalzo, Manuel Worcel

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

80 Scopus citations

Abstract

Background: Hydralazine and isosorbide dinitrate combination (H+ISDN), angiotensin-converting enzyme inhibitors, and beta-blockers have improved outcomes in heart failure (HF). Analysis of previous trials has shown that H+ISDN appears especially beneficial in African American patients. Methods and Results: The African-American Heart Failure Trial (A-HeFT) is double-blind, placebo-controlled, and includes African American patients with stable New York Heart Association Class III-IV HF on standard therapy. Patients must have prior HF-related events and left ventricular ejection fraction (LVEF) ≤35% or LVEF <45% with left ventricular internal diastolic dimension >2.9 cm/m2. Randomization to addition of placebo or BiDil (Nitro Med, Inc., Bedford, MA), a fixed combination of H+ISDN, is stratified for beta-blocker usage. All patients are treated and followed until the last patient entered completes 6 months of follow-up. The primary efficacy endpoint is a composite score including quality of life, death, and hospitalization for HF. At least 600 patients will be randomized; the first was randomized in June 2001. Conclusions: In addition to providing additional information on BiDil efficacy in HF, A-HeFT is the first HF trial aimed at a selected subgroup of patients and the first to use a new composite HF score as its primary efficacy endpoint.

Original languageEnglish (US)
Pages (from-to)128-135
Number of pages8
JournalJournal of Cardiac Failure
Volume8
Issue number3
DOIs
StatePublished - 2002

Keywords

  • BiDil
  • Hydralazine isosorbide dinitrate vasodilators

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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