BACKGROUND: We examined whether a fixed dose of both isosorbide dinitrate and hydralazine provides additional benefit in blacks with advanced heart failure, a subgroup previously noted to have a favorable response to this therapy. METHODS : A total of 1050 black patients who had New York Heart Association class III or IV heart failure with dilated ventricles were randomly assigned to receive a fi xed dose of isosorbide dinitrate plus hydralazine or placebo in addition to stan dard therapy for heart failure. The primary end point was a composite score made up of weighted values for death from any cause, a first hospitalization for hea rt failure, and change in the quality of life. RESULTS: The study was terminated early owing to a significantly higher mortality rate in the placebo group than in the group given isosorbide dinitrate plus hydralazine (10.2 percent vs. 6.2 p ercent, P=0.02). The mean primary composite score was significantly better in th e group given isosorbide dinitrate plus hydralazine than in the placebo group(- 0.1±1.9 vs. -0.5±2.0, P=0.01; range of possible values, -6 to +2), as were its individual components(43 percent reduction in the rate of death from any cau se[hazard ratio, 0.57; P=0.01] 33 percent relative reduction in the rate of firs t hospitalization for heart failure[16.4 percent vs. 22.4 percent, P=0.001], and an improvement in the quality of life [change in score, -5.6±20.6 vs. -2.7± 21.2, with lower scores indicating better quality of life; P=0.02; range of poss ible values, 0 to 105]). CONCLUSIONS: The addition of a fixed dose of isosorbide dinitrate plus hydralazine to standard therapy for heart failure including neur ohormonal blockers is efficacious and increases survival among black patients wi th advanced heart failure.
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