I-PRESERVE
Trial question
What is the role of irbesartan in patients with HFpEF?
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 HFpEF.
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 HFpEF, 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.
Open reference URL