Double-Blind, Placebo-Controlled Study of the Effects of Carvedilol in Patients With Moderate to Severe Heart Failure

• DOI: 10.1161/01.cir.94.11.2793
• Publication Date: 2012-06-12T00:34:42Z
• Authors: Milton Packer; Wilson S. Colucci; Jonathan D. Sackn...; Chang-seng Liang; David A. Goldscher; Israel Freeman; Marrick L. Kukin; Vithal Kinhal; James E. Udelson; Marc Klapholz; Stephen S. Gottlieb; David Pearle; Robert J. Cody; John J. Gregory; Nikki E. Kantrowitz; Thierry H. LeJemtel; Sarah T. Young; Mary Ann Lukas; Neil H. Shusterman
• Keywords: Carvedilol

Background Carvedilol has improved the symptomatic status of patients with moderate to severe heart failure in single-center studies, but its clinical effects have not been evaluated large, multicenter trials. Methods and Results We enrolled 278 (6-minute walk distance, 150 450 m) a left ventricular ejection fraction ≤0.35 at 31 centers. After an open-label, run-in period, each patient was randomly assigned (double-blind) either placebo (n=145) or carvedilol (n=133; target dose, 25 50 mg BID) for 6 months, while background therapy digoxin, diuretics, ACE inhibitor remained constant. Compared placebo, group had greater frequency improvement lower risk deterioration, as by changes NYHA functional class ( P =.014) global assessment progress judged =.002) physician <.001). In addition, treatment associated significant increase <.001) decrease combined morbidity mortality =.029). contrast, little effect on indirect measures benefit, including exercise tolerance quality-of-life scores. The drug were similar ischemic disease idiopathic dilated cardiomyopathy cause failure. Conclusions These findings indicate that, addition favorable survival, produces important benefits treated inhibitor. (Circulation. 1996;94:2793-2799.)