Double-blind, placebo-controlled study of the effects of carvedilol in patients with moderate to severe heart failure: The PRECISE Trial

Milton Packer, Wilson S. Colucci, Jonathan D. Sackner-Bernstein, 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

Research output: Contribution to journalArticle

555 Scopus citations

Abstract

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 in large, multicenter trials. Methods and Results: We enrolled 278 patients with moderate to severe heart failure (6-minute walk distance, 150 to 450 m) and a left ventricular ejection fraction ≤0.35 at 31 centers. After an open-label, run-in period, each patient was randomly assigned (double-blind) to either placebo (n=145) or carvedilol (n=133; target dose, 25 to 50 mg BID) for 6 months, while background therapy with digoxin, diuretics, and an ACE inhibitor remained constant. Compared with placebo, patients in the carvedilol group had a greater frequency of symptomatic improvement and lower risk of clinical deterioration, as evaluated by changes in the NYHA functional class (P=.014) or by a global assessment of progress judged either by the patient (P=.002) or by the physician (P<.001). In addition, treatment with carvedilol was associated with a significant increase in ejection fraction (P<.001) and a significant decrease in the combined risk of morbidity and mortality (P=.029). In contrast, carvedilol therapy had little effect on indirect measures of patient benefit, including changes in exercise tolerance or quality-of-life scores. The effects of the drug were similar in patients with ischemic heart disease or idiopathic dilated cardiomyopathy as the cause of heart failure. Conclusions: These findings indicate that, in addition to its favorable effects on survival, carvedilol produces important clinical benefits in patients with moderate to severe heart failure treated with digoxin, diuretics, and an ACE inhibitor.

Original languageEnglish (US)
Pages (from-to)2793-2799
Number of pages7
JournalCirculation
Volume94
Issue number11
DOIs
StatePublished - Jan 1 1996

Keywords

  • blockers, beta-adrenergic
  • carvedilol
  • heart failure

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Fingerprint Dive into the research topics of 'Double-blind, placebo-controlled study of the effects of carvedilol in patients with moderate to severe heart failure: The PRECISE Trial'. Together they form a unique fingerprint.

  • Cite this

    Packer, M., Colucci, W. S., Sackner-Bernstein, J. D., Liang, C. S., Goldscher, D. A., Freeman, I., Kukin, M. L., Kinhal, V., Udelson, J. E., Klapholz, M., Gottlieb, S. S., Pearle, D., Cody, R. J., Gregory, J. J., Kantrowitz, N. E., LeJemtel, T. H., Young, S. T., Lukas, M. A., & Shusterman, N. H. (1996). Double-blind, placebo-controlled study of the effects of carvedilol in patients with moderate to severe heart failure: The PRECISE Trial. Circulation, 94(11), 2793-2799. https://doi.org/10.1161/01.CIR.94.11.2793