The Effects of Enalapril on Survival in Patients with Reduced Left Ventricular Ejection Fractions and Congestive Heart failure (Treatment Trial) - SOLVD-Treatment

Jul 10, 2003
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Date Published:
01/01/1991
Date Updated:
07/10/2003
Original Posted Date:
07/10/2003
References

Description:

Enalapril vs. placebo for mortality in heart failure.

Hypothesis:

Enalapril will reduce mortality in patients with reduced left ventricular function and congestive heart failure when added to conventional therapy.

Study Design

Study Design:

Patients Screened: 39,924
Patients Enrolled: 2,569
NYHA Class: I=(11%), II=(57%),III=(30%), IV=(2%)
Mean Follow Up: 41 months
Mean Patient Age: 61
Female: 20
Mean Ejection Fraction: 25%

Patient Populations:

Patients with congestive heart failure and ejection fraction <35% already taking drugs other than ACE inhibitor for congestive heart failure.

Exclusions:

Age >80
Valvular disease
Angina requiring revascularization or unstable characteristics
Recent myocardial infarction (<1 month)
Creatinine >2.0
Any other disease shortening survival
Significant carotid artery disease

Primary Endpoints:

Mortality
all cause
cardiovascular

Secondary Endpoints:

Hospitalizations
Combined endpoints of death/hospitalizations for congestive heart failure
Ejection fraction measured by radionuclide (68%)
Contrast angiography (11%)
Echocardiogram (21%)

Drug/Procedures Used:

Enalapril (2.5 to 20 mg/day)
Background treatment with digoxin/diuretics

Concomitant Medications:

Digoxin (67%)
Diuretics (85%)
K-sparing diuretics (9%)
Vasodilators (51%)
Antiarrhythmics (22%)
Beta blockers (7.5%)
Calcium channel blockers (31%)
Anticoagulants (16%)
Antiplatelets (33%)
Potassium supplementation (50%)

Principal Findings:

Enalapril group had 16% reduction in all cause mortality.
Death due to progressive heart failure reduced by 22% with Enalapril.
Combined endpoint of death or hospitalization for worsening congestive heart failure reduced by 26% with Enalapril.
All cardiovascular deaths below 18% in Enalapril group.
No effect on death due to arrhythmia worsening congestive heart failure.

Interpretation:

Enalapril improves symptoms and decreases mortality in patients with mild to moderate symptomatic heart failure and left ventricular dysfunction when used with digoxin and diuretics.

References:

1. N Engl J Med 1991;325:293-302. Final results
2. Am J Cardiol 1995;75:1244-9. Ventricular arrhythmia substudy
3. Am J Cardiol 1996;78:890-5. Quality of life

Keywords: Enalapril, Digoxin, Diuretics, Heart Failure, Ventricular Dysfunction, Left


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