The Studies of Left Ventricular Dysfunction
(SOLVD)
Objectives:
This study was initiated in 1986 primarily to evaluate
the effects of enalapril, an ACE inhibitor, on long-term mortality and major
morbidity in a group of patients with left ventricular dysfunction. Two large,
separate trials were run concurrently as part of SOLVD: 1) a prevention trial
of patients with low ejection fraction but no overt symptoms of CHF and, 2) a
treatment trial of patients with low ejection fraction and symptoms of CHF. In
addition, patients at selected sites were entered into substudies to evaluate
the effect of enalapril on a number of intermiediate outcomes such as right and
left ventricular function and hemodynamics, LV mass and wall stress, hormones,
arrhythmias, exercise capacity, and quality of life in subsets of patients.
Lastly, a registry of 6,336 pateints with congestive heart failure of LV
dysfunction was designed to describe the clinical course of an unselected group
of patients.
Background:
Congestive Heart Failure (CHF) is a major and
increasingly recognized public health problem. The recognition that patients
with CHF often have elevated peripheral vascular resistance has led to the
introduction of vasodilator therapy, which has emerged as an important
component of its treatment. Of the vasodilators, the angiotensin-converting
enzyme (ACE) inhibitors appeared to be the most promising. In 1985 little was
known about the impact of any long-term drug treatment on survival.
Subjects:
There were two basic criteria for participants: 1) age
between 21 and 80 years, inclusive, and 2) LV ejection fraction of less than or
equal to 0.35, performed within 3 months of the day of consent. Ejection
Fraction was assessed by 1 of 3 techniques: 1) radionuclide LV angiography; 2)
LV contrast angiography, and 3) 2-dimensional echocardiography with ejection
fraction calculated by the area length method or Simpson's rule. A total of
2,569 patients were enrolled into the treatment study and 4,228 patients were
enrolled in the prevention study. The limited access dataset available through
the NHLBI contains the prevention and treatment study data and not the registry
data.
Conclusions:
In the prevention trial, a significant reduction in
the incidence of heart failure and the rate of related hospitalizations was
observed for patients in the enalapril arm. A statistically significant
reduction in mortality was not observed in the enalapril treatment arm;
however, there was a trend toward fewer total deaths and deaths due to
cardiovascular causes among the enalapril patients. (N Engl J Med 1992;
327:685-91.)
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Study Website |
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Study Documentation |
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Data Distribution Agreement |
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