I-PRESERVE
Trial question
What is the role of irbesartan in patients with HF and preserved ejection fraction?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
60.0% female
40.0% male
N = 4128
4128 patients (2491 female, 1637 male).
Inclusion criteria: patients with HF and a preserved LVEF.
Key exclusion criteria: intolerance to an angiotensin-receptor blocker; an alternative cause of the patient's symptoms; previous LVEF < 40%; history of acute coronary syndrome, coronary revascularization, stroke within the previous 3 months.
Interventions
N=2067 irbesartan (300 mg once daily).
N=2061 placebo (matching placebo once daily).
Primary outcome
Incidence of death from any cause or hospitalization for a cardiovascular cause
100.4
105.4
105.4/1000 py
79.1/1000 py
52.7/1000 py
26.4/1000 py
0.0/1000 py
Irbesartan
Placebo
No significant
difference ↔
No significant difference in the incidence of death from any cause or hospitalization for a cardiovascular cause (100.4/1000 py vs. 105.4/1000 py; HR 0.95, 95% CI 0.86 to 1.05).
Secondary outcomes
No significant difference in the incidence of death from any cause (52.6/1000 py vs. 52.3/1000 py; HR 1, 95% CI 0.88 to 1.14).
No significant difference in the incidence of hospitalization for cardiovascular causes (70.6/1000 py vs. 74.3/1000 py; HR 0.95, 95% CI 0.85 to 1.08).
No significant difference in the incidence of hospitalization for any cause (203.6/1000 py vs. 199.8/1000 py; HR 1.02, 95% CI 0.94 to 1.11).
Safety outcomes
No significant difference in serious adverse event.
Conclusion
In patients with HF and a preserved LVEF, irbesartan was not superior to placebo with respect to the incidence of death from any cause or hospitalization for a cardiovascular cause.
Reference
Barry M Massie, Peter E Carson, John J McMurray et al. Irbesartan in patients with heart failure and preserved ejection fraction. N Engl J Med. 2008 Dec 4;359(23):2456-67.
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