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The African-American Heart Failure Trial (A-HeFT) showed that nitrates and hydralazine improved mortality when used with ACE inhibitors and [beta]-blockers, but their value when added to traditional therapy is unknown in other racial groups.
The FDA reports the approval of BiDil was based in part on the results of the African-American Heart Failure Trial (A-HeFT).
In the study, called the African-American Heart Failure Trial, 525 African Americans with advanced heart failure received BiDil, along with standard treatment for heart failure and another 525 half received a placebo along with standard treatment.
Organizers of the African-American Heart Failure Trial (A-HeFT) defended the design based on results from past studies, which hinted that the effects of isosorbide dinitrate and hydralazine were strongest in African Americans, and the failure of many past studies to prove the value of cardiovascular medications in African Americans.
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