Problem Heart failure (EF < 35%; Stage III or IV)
Format -
Treatment Carvedilol
Control Placebo
Population 2289 patients
Inclusion criteria Symptoms of heart failure at rest or on minimal exertion
Left ventricular ejection fraction <25%
Receiving standard therapy (diuretic plus ACE inhibitor/angiotensin II-receptor antagonist)
Exclusion criteria Heart failure caused by uncorrected primary valvular disease or reversible form of cardiomyopathy
Cardiac transplant (or planned)
Severe primary pulmonary, renal, or hepatic disease
Contraindication to beta-blocker therapy
Coronary revascularization, acute myocardial or cerebral ischemic event or a sustained or hemodynamically destabilizing ventricular tachycardia or fibrillation within the previous two months
Treatment by alpha-adrenergic blocker, calcium channel blocker, or class I antiarrhythmic drug within the previous four weeks or beta-blocker within the previous two months
Systolic blood pressure<85 mm Hg
Heart rate < 68 /min
Serum creatinine >2.8 mg/dL
Serum potassium < 3.5 mmol/L or >5.2 mmol/L
Increase of more than 0.5 mg/dL in the serum creatinine
Change in body weight of more than 1.5 kg during the screening period (3 to 14 days)
Follow-up Mean 316 days
Primary endpoint All-cause mortality
Secondary endpoint(s) Combined endpoint of death and all-cause hospital admissions
Details -
Brief summary:
PAPER: The Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial
Date 2 Feb 2001
Journal Curr Control Trials Cardiovasc Med. 2001;2(1):20-23.
Information Significantly reduced:
-All-cause mortality
-Combined endpoint of all-cause mortality and hospitalisation