Clinical TrialsAfrican-American Heart Failure Trial (A-HeFT): Rationale, design, and methodology*,**
Section snippets
Ethics and informed consent
The final study protocol was reviewed and approved by appropriate Institutional Review Boards, and all patients must give written informed consent before the performance of any screening procedures.
Study population
Patients are male or female at least 18 years old and African American by self-declaration. They must have HF diagnosed for at least 3 months, with New York Heart Association (NYHA) Class III-IV symptoms at screening while receiving a stable therapeutic regimen for HF. There is no prespecified
Endpoints
The primary efficacy variable is a composite score of clinical outcomes including death, first hospitalization for HF, and QOL measured at 6 months. The scoring system is shown in Table 2.Variable Scored Criteria Score Death Death from any cause anytime during trial −3 Alive at end of trial 0 Hospitalization A first hospitalization for heart failure −1 No hospitalization for heart failure 0 Change in Quality of Life at 6 months* Reduction by −10 or more units = markedly
Preliminary recruitment experience
The first patient was randomized into the trial in June 2001. As of March 1, 2002, 207 patients have been randomized. Given the small number of patients currently entered, it is premature to provide any of their baseline demographics or HF historical data because they may not be a representative sample.
Discussion
The overall efficacy of the free combination of H+ISDN has been established by the V-HeFT trials. The V-HeFT I trial demonstrated its beneficial effect on survival compared to placebo or prazosin, and V-HeFT II observed the same mortality rate on H+ISDN, though this effect was not as good as that of enalapril.4, 5 However, H+ISDN was more effective than enalapril on exercise capacity and QOL. Taken together these results indicate that H+ISDN produces beneficial effects in the broad population
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2012, Heart Failure ClinicsCitation Excerpt :Post hoc analysis of the outcomes by ethnicity revealed that African Americans derived greater benefit from the combination of ISDN/HYD (Fig. 4).76 These data provided the context for the hypothesis for the African American Heart Failure Trial (A-HeFT), the first randomized trial of combined NO donor and antioxidant targeting enhancement of NO bioavailability, rather than the hemodynamic effects of these drugs.77,78 The A-HeFT trial77,78 assessed the effect of combined ISDN/HYD (with nitrates as NO donor and hydralazine as antioxidant) on cardiovascular outcomes in African American patients with advanced heart failure.
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Reprint requests: Joseph A. Franciosa, MD, 350 East 79th Street, Apartment 39C, New York, NY 10021.
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Supported by a grant from NitroMed Inc, Bedford, Massachusetts.