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

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

Authors :
Joseph A. Franciosa
Keith C. Ferdinand
Clyde W. Yancy
Elizabeth Ofili
Manuel Worcel
Joseph Loscalzo
Jay N. Cohn
Susan Ziesche
Anne L. Taylor
Adeoye Y. Olukotun
Source :
Journal of cardiac failure. 8(3)
Publication Year :
2002

Abstract

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.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)or = 35% or LVEF45% with left ventricular internal diastolic dimension2.9 cm/m(2). 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.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.

Details

ISSN :
10719164
Volume :
8
Issue :
3
Database :
OpenAIRE
Journal :
Journal of cardiac failure
Accession number :
edsair.doi.dedup.....4f20df7a42b48b22dedba7f1bf42dbdb