The Effects of Enalapril on Survival in Patients with Reduced Left Ventricular Ejection Fractions and Congestive Heart failure (Treatment Trial) - SOLVD-Treatment
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
Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure
Keywords: Enalapril, Digoxin, Diuretics, Heart Failure, Ventricular Dysfunction, Left
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