6/28/23, 12:16 AM COPERNICUS Pathway Feedback Search Clinical Topics Home Studies COPERNICUS COPERNICUS Disease Heart failure Trial question What is the role of carvedilol on the morbidity of patients with severe chronic HF? Study design Multi-center Double blinded RCT Population Characteristics of study participants 21.0% female N = 2289 79.0% male 2289 patients (470 female, 1819 male) Inclusion criteria: patients with symptoms of HF at rest or on minimal exertion and with an ejection fraction < 25% (but not volume-overloaded) Key exclusion criteria: HF caused by uncorrected primary valvular disease or a reversible form of cardiomyopathy; severe primary pulmonary, renal, or hepatic disease; or contraindication to -blocker therapy Interventions N=1156 carvedilol (target dose of 25 mg BID for an average of 10.4 months) N=1133 placebo (matching placebo for an average of 10.4 months) Primary outcome Death or hospitalization for a cardiovascular reason 41.6 % 41.6 https://web.pathway.md/studies/rec4NvXjaiEdZ5IF0 1/2 6/28/23, 12:16 AM COPERNICUS Pathway 31.2 % 30.2 20.8 % Significant decrease 10.4 % NNT = 9 0.0 % Carvedilol Placebo Significant decrease in death or hospitalization for a cardiovascular reason (30.2% vs. 41.6%; RR 0.73, 95% CI 0.63 to 0.84) Secondary outcomes Significant decrease in death or hospitalization for HF (25.5% vs. 37.9%; RR 0.69, 95% CI 0.59 to 0.81) Safety outcomes Significant differences in serious adverse event (39.0% vs. 45.5%, p = 0.002). Conclusion In patients with symptoms of HF at rest or on minimal exertion and with an ejection fraction < 25% (but not volume-overloaded), carvedilol was superior to placebo with respect to death or hospitalization for a cardiovascular reason. Reference Packer M, Fowler MB, Roecker EB et al. Effect of carvedilol on the morbidity of patients with severe chronic heart failure: results of the carvedilol prospective randomized cumulative survival (COPERNICUS) study. Circulation. 2002 Oct 22;106(17):2194-9. Open reference URL https://web.pathway.md/studies/rec4NvXjaiEdZ5IF0 2/2