Baseline Quality of Life as a Predictor of Mortality and Hospitalization in 5,025 Patients With Congestive Heart Failure

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Abstract

This study examined the independent relation of health-related quality of life (HRQL) to mortality and congestive heart failure (CHF)-related hospitalizations in patients with an ejection fraction of <0.35 followed for a mean of 36.5 months. A brief HRQL questionnaire was administered at baseline to patients randomized to placebo or enalapril in the Studies of Left Ventricular Dysfunction (SOLVD) trial. Participants had an ejection fraction of <0.35 and either symptomatic CHF (treatment trial, n = 2,465) or asymptomatic CHF (prevention trial, n = 2,560). Baseline assessment of HRQL predicted mortality and CHF-related hospitalizations in symptomatic and asymptomatic patients randomized to enalapril and placebo treatment. Domains that were the stronger univariate predictors of mortality and CHF-related hospitalizations were activities of daily living (relative risk [RR] for mortality: 1.163, p <0.000; for hospitalization: 1.215, p <0.000), general health (RR for mortality: 1.205, p <0.000; for hospitalization: 1.188, p <0.000), and social functioning (RR for mortality 1.098, p <0.000; for hospitalization: RR 1.156, p <0.000). In the multivariate model, activities of daily living (RR for mortality 1.41, p <0.000; for hospitalization: RR 1.43, p <0.002), general health (RR for mortality 1.21, p <0.000; for hospitalization RR 1.16, p <0.013) and heart failure symptoms (RR for mortality 1.02, p <0.025; for hospitalization RR 1.03, p <0.004) were found to be independent risk factors. HRQL independently predicted mortality and CHF-related hospitalizations after adjustment for ejection fraction, age, treatment, and New York Heart Association classification in patients with an ejection fraction of <0.35, randomized to enalapril and placebo treatment. HRQL provides additional clinical information regarding disease course and outcome that is not captured by traditional indexes of clinical status.

(Am J Cardiol 1996;78:890–895)

Section snippets

METHODS

Studies of left ventricular dysfunction trials: A description of the study design has been provided previously.4, 5, 6 Six thousand seven hundred ninety-seven subjects, aged 21 to 80 years, from 23 centers were randomized to receive double-blind enalapril (2.5 to 20 mg/day) or placebo to evaluate effects on patients with CHF (ejection fraction ≤ 0.35). Two thousand five hundred sixty-nine patients with CHF symptoms were enrolled in the treatment trial and 4,228 patients with no CHF symptoms

RESULTS

A summary of clinical characteristics of patients enrolled in the study are described in Table 2. The HRQL questionnaire was completed by 2,465 of the 2,569 patients (96%) enrolled in the treatment trial and the first 2,560 of the 4,228 patients (61%) enrolled in the prevention trial. Analysis of patient characteristics revealed that the groups randomized to enalapril and placebo within each trial were similar with respect to overall HRQL ratings.[3] Approximately 5% of questions on the HRQL

DISCUSSION

Baseline assessment of HRQL independently predicted mortality and CHF-related hospitalizations in symptomatic and asymptomatic patients randomized to enalapril or placebo treatment. The domains of ADL and general health, both in the univariate and multivariate analyses, predicted mortality and CHF-related hospitalizations. Quality-of-life indexes provided additional predictive value with respect to both mortality and CHF-related hospitalizations, above and beyond the predictive power of such

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    *

    A complete list of the SOLVD investigators may be found in Bangdiwala SI, Weiner DH, Bourassa MG, Friesinger GC II, Ghali JK, Yusuf S, for the SOLVD Investigators. Studies of Left Ventricular Dysfunction (SOLVD) Registry: rationale, design, methods and description of baseline characteristics. Am J Cardiol 1992;70:347–353.

    *a

    A complete list of the SOLVD investigators may be found in Bangdiwala SI, Weiner DH, Bourassa MG, Friesinger GC II, Ghali JK, Yusuf S, for the SOLVD Investigators. Studies of Left Ventricular Dysfunction (SOLVD) Registry: rationale, design, methods and description of baseline characteristics. Am J Cardiol 1992;70:347–353.

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