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

Rector, T.S., Carson, P.E., Anand, I.S., McMurray, J.J. , Zile, M.R., McKelvie, R.S., Komajda, M., Kuskowski, M. and Massie, B.M. (2012) 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. Circulation: Heart Failure, 5(2), pp. 217-225. (doi: 10.1161/CIRCHEARTFAILURE.111.964221)

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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. <p/>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). <p/>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.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:McMurray, Professor John
Authors: Rector, T.S., Carson, P.E., Anand, I.S., McMurray, J.J., Zile, M.R., McKelvie, R.S., Komajda, M., Kuskowski, M., and Massie, B.M.
College/School:College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
Journal Name:Circulation: Heart Failure
Publisher:Lippincott Williams and Wilkins
ISSN:1941-3289
ISSN (Online):1941-3297
Published Online:20 January 2012

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