| Authors |
| The SOLVD investigators |
| Title |
| Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure |
| References |
| N Engl J Med 1991;325:293-302 |
| Background |
| At the time of the initiation of this landmark trial, ACE Inhibitors (ACEi) have been shown to reduce mortality rates only in patients with NYHA class IV symptoms. |
| Purpose |
| To determine if enalapril, when added to standard medication therapy, positively affects clinical outcomes and survival rates in congestive heart failure patients with low ejection fractions (≤0.35) and milder symptoms. |
| Design |
- Multicenter, randomized, double-blind, placebo controlled trial
- 2569 patients with congestive heart failure and LVEF ≤0.35
- Baseline characteristic: 90% of patient enrolled had NYHA class II and III symptoms
|
| Exclusion Criteria |
- >80 years of age
- valvular disease requiring surgery, unstable angina, angina with possible revascularization, MI within one month
- severe pulmonary disease, serum creatinine >177 µmol/L
- any other clinically significant coexisting condition which would shorten or impede completion of trial
|
| Follow-Up |
| Average 41.4 months (22-55 months) |
| Treatment Regimen |
- Enalapril 2.5 or 5 mg twice daily, titrated to optimal dose of 10 mg twice daily (as tolerated by patient and physician’s discretion) vs. placebo.
- Follow-up at week 2, 6, month 4 and then every four months until completion of trial – if worsening heart failure, then up titration of diuretic or addition of other vasodilator
|
| Results |
Primary Endpoints Mortality Rate:35.2% (enalapril) vs. 39.7% (placebo); RR 16% (5-26%), p<0.0036
Secondary Endpoints (see study for complete list) Enalapril
n=1285 | Placebo
n=1284 | Risk Reduction | p |
|---|
| Deaths or heart failure hospitalization |
|---|
| 47.7% | 57.3% | 26% (18-34%) | <0.0001 | | CV death (all cause) |
|---|
| 31.1% | 35.9% | 18% (6-28%) | <0.002 | | CV death due to heart failure or arrhythmia with CHF |
|---|
| 16.3% | 19.5% | 22% (6-35%) | <0.0045 | | CV death due to MI |
|---|
| 3.1% | 4.1% | 28% (-8-52%) | <0.07 | - CV death due to arrhythmia without worsening heart failure and non-CV death causes were not significantly improved with enalapril
|
| Summary |
| Enalapril reduces death and HF hospitalizations in HF patients with ejection fractions less than 35%. |