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COPERNICUS TRIAL |
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|---|---|
| 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 |