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SOLVD TRIAL |
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|---|---|
| Problem | Heart failure (Asymptomatic) |
| Format | Double-blinded multi-center RCT |
| Treatment | Enalapril |
| Control | Placebo |
| Population | 4228 patients |
| Inclusion criteria | Patients with congestive heart failure and ejection fractions of 0.35 or less who were already taking drugs other than an angiotensin-converting—enzyme inhibitor as part of conventional therapy for congestive heart failure were eligible for the study. |
| Exclusion criteria | Use of an angiotensin-converting—enzyme inhibitor (28 percent) Cardiovascular problems (12 percent) Contraindications to the use of an angiotensin-converting—enzyme inhibitor (11 percent) Lack of consent by the patient (11 percent) Administrative reasons (21 percent) Cancer or other life-threatening disease (12 percent) Other reasons (5 percent). |
| Follow-up | Mean 37.4 months |
| Primary endpoint | Mortality |
| Secondary endpoint(s) | A subsidiary hypothesis was that enalapril would reduce the incidence of heart failure and the rate of hospitalization for heart failure. The last two end points were combined with mortality to avoid the problem of competing risks. |
| Details | Enalapril vs placebo in addition to diuretics & digoxin |
| Brief summary: | ACEi in asymptomatic LV dysfunction reduced incidence and hospitalisation for CCF |
| PAPER: Effect of enalapril on mortality and the development of heart failure in asymptomatic patients with reduced left ventricular ejection fractions. | |
|---|---|
| Date | 3 Sep 1992 |
| Journal | N Engl J Med. 1992 Sep 3;327(10):685-91. |
| Information | Asymptomatic patients with EF < 35% Significantly reduced -Incident of heart failure -Hospital admissions for heart failure Trend towards fewer deaths |