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Clinical characteristics of patients in studies of left ventricular dysfunction (SOLVD)
D Johnstone1, M Limacher, M Rousseau
1Division of Epidemiology and Clinical Applications Clinical Trials Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland 20892.
Insights
The Studies of Left Ventricular Dysfunction (SOLVD) trials compared patient characteristics in enalapril treatment and prevention arms. Findings highlight demographic and comorbidity differences influencing clinical trial enrollment for heart failure.
Area of Science:
- Cardiology
- Clinical Trials
- Public Health
Background:
- Left ventricular (LV) dysfunction is a critical determinant of heart failure and mortality.
- The Studies of Left Ventricular Dysfunction (SOLVD) trials investigated enalapril's impact on patients with LV dysfunction.
- Understanding baseline characteristics is crucial for trial design and patient stratification.
Purpose of the Study:
- To compare the baseline clinical characteristics of patients enrolled in the SOLVD treatment and prevention trials.
- To identify differences in demographics, medical history, and risk factors between the two trial cohorts.
Main Methods:
- Analysis of baseline data from over 6,700 patients screened for LV dysfunction.
- Comparison of patient demographics, including gender and race, between the prevention and treatment arms.
- Evaluation of comorbidities such as ischemic heart disease, myocardial infarction, hypertension, and diabetes.
Main Results:
- Ischemic heart disease was the predominant cause of LV dysfunction in both trials.
- Treatment trial patients exhibited a higher prevalence of women, non-Caucasians, hypertension, and diabetes compared to the prevention trial.
- Prior myocardial infarction was more common in the prevention trial (80%) than the treatment trial (66%).
Conclusions:
- Significant differences exist in the baseline characteristics of patients enrolled in the SOLVD prevention and treatment trials.
- These disparities, particularly in gender, race, and comorbidities, may influence trial outcomes and generalizability.
- Trial enrollment criteria and patient populations require careful consideration for effective cardiovascular research.
Abstract:
The Studies of Left Ventricular Dysfunction (SOLVD) trials were designed to evaluate the effects of enalapril on long-term mortality in patients with severe left ventricular (LV) dysfunction. Patients with LV ejection fractions less than or equal to 0.35 and symptoms of congestive heart failure (CHF) were enrolled in the treatment trial, whereas those with no history of overt CHF and taking no treatment directed for LV dysfunction were enrolled in the prevention trial. The baseline clinical characteristics of SOLVD patients were compared to characterize differences between patients in these 2 separate but concurrent trials. From over 70,000 patients screened with LV dysfunction, 4,228 patients were enrolled in the prevention trial and 2,569 patients in the treatment trial. Ischemic heart disease was the primary cause of LV dysfunction in both prevention (83%) and treatment (71%) trial patients. Prior myocardial infarction was present in 80% of the prevention and 66% of the treatment trial patients (p less than 0.001). In the prevention trial, infarction was recent (less than or equal to 6 months) in 27% patients and remote (greater than 6 months) in 57% patients. Treatment trial patients had proportionately more women (20 vs 13%; p less than 0.001) and non-Caucasians (20 vs 14%; p less than 0.001), as well as the coexisting risk factors of hypertension (42 vs 37%; p less than 0.001) and diabetes (26 vs 15%; p less than 0.001) than did prevention trial patients. Clinical characteristics of patients in both trials were influenced by the gender and race of enrolled patients. Similarly, coronary artery bypass surgery was performed less often in women and non-Caucasians.(ABSTRACT TRUNCATED AT 250 WORDS)