title: 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.
  
  
  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.
authors.affiliation: Department of Veterans Affairs Health Care System and Department of Medicine, University of Minnesota, Minneapolis, MN 55417, USA. thomas.rector@va.gov
authors.forename: Thomas S
authors.initials: TS
authors.lastname: Rector
authors.forename: Peter E
authors.initials: PE
authors.lastname: Carson
authors.forename: Inder S
authors.initials: IS
authors.lastname: Anand
authors.forename: John J
authors.initials: JJ
authors.lastname: McMurray
authors.forename: Michael R
authors.initials: MR
authors.lastname: Zile
authors.forename: Robert S
authors.initials: RS
authors.lastname: McKelvie
authors.forename: Michel
authors.initials: M
authors.lastname: Komajda
authors.forename: Michael
authors.initials: M
authors.lastname: Kuskowski
authors.forename: Barry M
authors.initials: BM
authors.lastname: Massie
mesh_terms: D000368:Aged; D000804:Angiotensin II; D047228:Angiotensin II Type 1 Receptor Blockers / Q000008:administration & dosage / Q000627:therapeutic use; D001713:Biphenyl Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D017052:Hospital Mortality / Q000639:trends; D006801:Humans; D000077405:Irbesartan; D008297:Male; D008910:Minnesota / Q000453:epidemiology; D013318:Stroke Volume / Q000187:drug effects / Q000502:physiology*; D011795:Surveys and Questionnaires; D015996:Survival Rate / Q000639:trends; D013599:Systole; D013777:Tetrazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D016277:Ventricular Function, Left / Q000187:drug effects / Q000502:physiology*
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D001713:Biphenyl Compounds; D013777:Tetrazoles; D000804:Angiotensin II; D000077405:Irbesartan