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


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) < or = 35% or LVEF <45% with left ventricular internal diastolic dimension >2.9 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.


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.
Zena and Michael A. Wiener Cardiovascular Institute, Mt. Sinai School of Medicine, New York, New York, USA.
Joseph A
JA
Franciosa
Anne L
AL
Taylor
Jay N
JN
Cohn
Clyde W
CW
Yancy
Susan
S
Ziesche
Adeoye
A
Olukotun
Elizabeth
E
Ofili
Keith
K
Ferdinand
Joseph
J
Loscalzo
Manuel
M
Worcel
D000293:Adolescent; D000328:Adult; D000368:Aged; D044383:Black People; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006333:Heart Failure / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D006830:Hydralazine / Q000627:therapeutic use*; D007258:Informed Consent; D007548:Isosorbide Dinitrate / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D012107:Research Design; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000627:therapeutic use*; D018487:Ventricular Dysfunction, Left / Q000188:drug therapy; D001741:Black or African American
D004338:Drug Combinations; D014665:Vasodilator Agents; C431665:isosorbide-hydralazine combination; D006830:Hydralazine; D007548:Isosorbide Dinitrate