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CONSENSUS TRIAL |
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|---|---|
| Problem | Heart failure (Stage IV) |
| Format | Double-blinded multi-center RCT |
| Treatment | Enalapril |
| Control | Placebo |
| Population | 253 patients |
| Inclusion criteria | Patients with severe congestive heart failure (New York Heart Association [NYHA] functional class IV) |
| Exclusion criteria | Acute pulmonary oedema Hemodynamically important aortic or mitral-valve stenosis Myocardial infarction within the previous two months Unstable angina Planned cardiac surgery Right heart failure due to pulmonary disease Serum creatinine concentration above 300 Î_mol per liter. |
| Follow-up | Median 188 days |
| Primary endpoint | Six-month mortality Cause of death (Cause of death was classified by two investigators independently, on the basis of detailed reports, before the code was broken. Causes of death were described in accordance with a modified version of the American Heart Association's recommendations. Sudden death was defined as death within one hour of the onset of new symptoms. Unwitnessed deaths were classified according to the length of time from the last observation when the patient was alive to the estimated time of death) |
| Secondary endpoint(s) | 12-month and overall mortality during the entire trial period, according to the \intention-to-treat\" principle." |
| Details | - |
| Brief summary: | ACEi reduce CCF progression in NYHA 4, mortality, improve symptoms |
| PAPER: Effects of enalapril on mortality in severe congestive heart failure. Results of the Cooperative North Scandinavian Enalapril Survival Study | |
|---|---|
| Date | 4 Jun 1987 |
| Journal | N Engl J Med. 1987 Jun 4;316(23):1429-35. |
| Information | Reductions in -All-cause mortality -NYHA classification -CHF progression No reduction in sudden cardiac death |