TY - JOUR
T1 - The African-American heart failure trial
T2 - Background, rationale and significance
AU - Taylor, Anne L.
AU - Cohn, Jay N.
AU - Worcel, Manuel
AU - Franciosa, Joseph A.
PY - 2002/9/1
Y1 - 2002/9/1
N2 - 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.
AB - 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.
KW - Heart failure
KW - Hydralazine
KW - Isosorbide dinitrate
KW - Vasodilators
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M3 - Article
C2 - 12392039
AN - SCOPUS:0036729830
SN - 0027-9684
VL - 94
SP - 762
EP - 769
JO - Journal of the National Medical Association
JF - Journal of the National Medical Association
IS - 9
ER -