Assessment of Long-Term Effects of Irbesartan on Heart Failure With Preserved Ejection Fraction as Measured by the Minnesota Living With Heart Failure Questionnaire in the Irbesartan in Heart Failure With Preserved Systolic Function (I-PRESERVE) Trial

Abstract

Background— The Minnesota Living with Heart Failure Questionnaire (MLHFQ) was used in a large, multinational, randomized, placebo-controlled trial to measure adverse effects of heart failure with preserved ejection fraction (HF-PEF) on patients' lives and the effects of irbesartan. Methods and Results— Patients with symptomatic HF-PEF were randomly assigned to irbesartan (up to 300 mg daily) or placebo. The MLHFQ was administered at baseline (n=3605), month 6 (n=3137), month 14 (n=2904), and the end of study (median, 56 months, n=2205). Baseline MLHFQ scores of 43±21 indicated that HF-PEF had a substantial adverse effects. Estimated retest reliability was 0.80. Baseline MLHFQ scores were associated with other measures of the severity of heart failure including symptoms, signs of congestion, cardiac structure, and time to hospitalizations or deaths attributed to heart failure. Slight improvement in shortness of breath or fatigue was associated with significant improvement in MLHFQ scores (−5.9 and −5.0, P <0.0001). Compared with placebo, further improvement in MLHFQ scores was not observed with irbesartan after 6 months (mean adjusted difference, 0.4; 95% confidence interval, −0.8 to 1.7), 14 months (0.5; 95% confidence interval, −0.9 to 1.8), or the end of study (2.0; 95% confidence interval, −4.1 to 0.01). Conclusions— The MLHFQ scores are a reliable, valid, and sensitive measure of the adverse impact of HF-PEF on patients' lives. Irbesartan did not substantially improve MLHFQ scores during a long period of follow-up. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00095238.