The African-American Heart Failure Trial: background, rationale and significance.
New treatments have improved outcomes in heart failure (HF), but applicability of these advances may be limited in African Americans. Analysis of previous trials has shown that a combination of hydralazine (H) plus isosorbide dinitrate (ISDN) may be especially beneficial in African Americans with HF. The African American Heart Failure Trial (A-HeFT) is a double-blind, randomized, and placebo-controlled trial in African American patients with stable NYHA Class III-IV HF while on standard therapy. Randomization to addition of BiDil, a fixed combination of H+ISDN, or placebo, will be stratified for beta-blocker usage, and all patients will be treated and followed until the last patient entered has completed six months of follow-up. The primary efficacy endpoint will be a composite score including quality of life, deaths, and hospitalizations for HF. At least 600 patients will be randomized. The first patient was randomized in June, 2001. Besides additional testing of H+ISDN in HF, A-HeFT will be the first HF trial aimed at a subgroup of African American patients, as well as the first to use a new composite HF score as its primary efficacy endpoint.
Taylor
Anne L
AL
University of Minnesota, Minneapolis, USA.
Cohn
Jay N
JN
Worcel
Manuel
M
Franciosa
Joseph A
JA
D001741:Black or African American; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D004338:Drug Combinations; D006333:Heart Failure / Q000188:drug therapy* / Q000208:ethnology*; D006801:Humans; D006830:Hydralazine / Q000627:therapeutic use*; D007548:Isosorbide Dinitrate / Q000627:therapeutic use*; D012107:Research Design
D002317:Cardiovascular Agents; D004338:Drug Combinations; C431665:isosorbide-hydralazine combination; D006830:Hydralazine; D007548:Isosorbide Dinitrate