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
Key result
Irbesartan did not substantially improve MLHFQ scores compared to placebo in patients with HF-PEF at the end of study (mean adjusted difference 2.0; 95% CI -4.1 to 0.01).
Why the study?
Does irbesartan improve quality of life as measured by MLHFQ scores in patients with symptomatic HF-PEF?
Population
3,605 patients with symptomatic heart failure with preserved ejection fraction (HF-PEF), multinational
Comparison
Irbesartan up to 300 mg daily vs Placebo
Design
RCT, randomly assigned, placebo-controlled
Follow-up
median 56 months
Authors
Discussion
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Implication
Irbesartan confers no quality-of-life benefit in HF-PEF; reinforces neutral ARB effects and redirects focus to alternative therapies.
Study Design
Type
RCT (n=3,605)
Randomization
Randomized
Multicenter
Yes
Structured PICO
Does irbesartan improve quality of life as measured by MLHFQ scores in patients with symptomatic HF-PEF?
P
Population
3,605 patients with symptomatic heart failure with preserved ejection fraction followed for a median of 56 months.
I
Intervention
Irbesartan up to 300 mg daily
C
Comparator
Placebo
O
Outcome
Minnesota Living with Heart Failure Questionnaire (MLHFQ) scores at month 6, month 14, and end of study (median 56 months)patient reported
Main Result
Mean Difference: 2 (95% CI -4.1–0.01)
Irbesartan does not significantly improve long-term quality of life in patients with heart failure with preserved ejection fraction.
Cite This Study
Rector et al. (2012) conducted an RCT in Heart failure with preserved ejection fraction (HF-PEF) (n=3,605). Irbesartan vs. Placebo was evaluated on Improvement in MLHFQ scores at the end of study (mean adjusted difference 2.0, 95% CI -4.1 to 0.01). Irbesartan did not substantially improve MLHFQ scores compared to placebo in patients with HF-PEF at the end of study (mean adjusted difference 2.0; 95% CI -4.1 to 0.01).