A-HeFT

A-HeFT

African-American heart failure trial. A randomised, double-blind, placebo-controlled study of 1,100 African-American men and women with moderate to severe congestive heart failure, categorised as New York Heart Association (NYHA) heart failure classifications III and IV. A-HeFT assessed the effects of an NO-enhancing drug, isosorbide dinatrate (BiDil). The trial was stopped early because of marked improvement in Black patients in whom it reduced mortality by 43% and hospitalisations by 39%. Isosorbide became the first heart-failure medication to specifically address endothelial dysfunction, and is the first race-based prescription drug.
References in periodicals archive ?
Prognostic Import of the Corin I555(P568) Allele in African-Americans with Moderate to Severe Heart Failure: Results from the A-HeFT Trial.
Only BiDil was studied and proven effective in A-HeFT and it is unknown whether other formulations provide the same clinical benefits.
In addition to the A-HeFT confirmatory trial, NitroMed is seeking FDA approval of BiDil for African American patients with heart failure based on results from two completed six-year mortality studies (V-HeFT I and II) in which BiDil appeared to provide a selective benefit to African Americans.
Puckrein said, "The National Minority Health Month Foundation believes that the results of the A-HeFT trial provide the first step towards what must be a long-term commitment on the part of government, industry and organized medicine to hone our ability to identify the causes and appropriate therapies for all conditions that compromise the health and well-being of America's multi-ethnic population.
The A-HeFT trial is a double blind, placebo-controlled study designed to confirm the safety and efficacy of BiDil in African American patients with heart failure.
We are proud to co-sponsor the A-HeFT trial, the first clinical heart failure trial in an all African American population, which we hope will help to further the understanding and development of heart failure treatments," states B.
A-HeFT was a double-blind, placebo-controlled trial with 170 clinical sites nationwide.
The A-HeFT trial was halted early in July 2004 by the Data Safety Monitoring Board and Steering Committee due to the significant positive effect on mortality seen with BiDil.
said that although she supported approval, she was not satisfied using self-identification as being African American as a surrogate for a biologic process, and did not support the label targeting this group because the underlying rationale of A-HeFT was a biologic reason.
27) Frequently Asked Questions About The A-Heft Trial Background For Abc Members.
In A-HeFT, self-identified black patients taking BiDil in addition to current standard heart failure therapies were compared to those taking a placebo in addition to current standard therapies.
The recent publication of the A-HeFt study (7) and the FDA approval of a fixed-dose combination of hydralazine and isosorbide-dinitrate BiDil (8) for use in African-American patients with heart failure mean that clinicians will be faced with the difficult task of initiating and monitoring their African-American patients with heart failure on hydralazine.