The study protocol was reviewed and approved by the institutional review board at each site. Blocks of 4 patients per stratum were used, with each site allowed to randomize up to 6 blocks of patients (24 patients) in the non–beta-blocker group and up to 10 blocks (40 patients) in the beta-blocker group.Eligible patients were required to be receiving stable doses of therapy for heart failure and to have had a variation in body weight of less than 2.5 percent in the two weeks before randomization. Rather than studying a large heterogeneous population, we examined a specific population in whom efficacy was more likely to be established. Prescribing spironolactone together with a thiazide diuretic is not a new concept, having been reported since 1962. Dr. Yancy has received consulting and lecture fees from the company. We compared the change in the quality of life between groups using a two-sample t-test for the difference in scores (on the basis of the data obtained at six months or, when unavailable, data from the three-month assessment carried forward).Additional descriptive statistics were estimated for patients' characteristics and reported as the mean (±SD) or the total number (and percentage). Sep 8, 2020 ); Heartbeats Life Center and Xavier University, New Orleans (K.F. ); University of North Carolina, Chapel Hill (K.A. Site monitoring, data collection, and data management were performed by Medifacts International, a clinical research organization. All patients gave written informed consent. The study sponsor was NitroMed. — both in Minneapolis; University of Texas Southwestern Medical Center, Dallas (C.Y. Plasma levels of apparent hydralazine decline with a half-life of 3-7 hours. The trial population was limited to patients who identified themselves as black, a subgroup that had had a particularly favorable response to this therapy in retrospective analyses.The 43 percent reduction in the mortality rate in the group given isosorbide dinitrate plus hydralazine occurred among patients who were well treated with a background regimen of neurohormonal-inhibitor drugs. Advertising revenue supports our not-for-profit mission.Check out these best-sellers and special offers on books and newsletters from Mayo Clinic. Our general interest e-newsletter keeps you up to date on a wide variety of health topics.Along with its needed effects, a medicine may cause some unwanted effects. (P.C. Since the composite measure used in this trial had not been evaluated in previous trials, two interim analyses were prespecified in the protocol to permit an assessment of the adequacy of the sample size without knowledge of efficacy. The following were also reasons for exclusion: an acute myocardial infarction, acute coronary syndrome, or stroke within the preceding three months; cardiac surgery or percutaneous coronary intervention within the preceding three months or the likelihood of a requirement for such procedures during the study period; the presence of clinically significant valvular heart disease, hypertrophic or restrictive cardiomyopathy, active myocarditis, or uncontrolled hypertension; a history of cardiac arrest or life-threatening arrhythmias within the preceding three months (unless they had been treated with an implantable defibrillator); treatment with parenteral inotropic agents within one month before randomization; a potential need for cardiac transplantation; the presence of symptomatic hypotension; the presence of an illness other than heart failure that was likely to result in death within the study period; an inability to complete the quality-of-life questionnaire; and contraindications to the use of nitrate or hydralazine therapy.Randomization was performed centrally by Medifacts International, with stratification according to the use or nonuse of beta-blockers as background therapy. The specific techniques for assessing the adequacy of the sample size were based on methods described by Cui et al.The primary efficacy comparison included all participants who had undergone randomization (intention-to-treat analysis). There was no significant change in the heart rate between the two groups.We confirmed the findings in V-HeFT I of the efficacy and survival advantage of a combination of isosorbide dinitrate plus hydralazine added to standard background therapy in patients with moderate-to-severe heart failure. Hydralazine is rapidly absorbed after oral administration, and peak plasma levels are reached at 1-2 hours. For the analysis of death from any cause, we used standard Kaplan–Meier survival methods with the log-rank test. The study design has been described previously.Patients 18 years of age or older, self-identified as black (defined as of African descent), who had had NYHA class III or IV heart failure for at least three months were eligible for screening. 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