6/28/23, 11:31 PM I-PRESERVE Pathway Feedback Search Clinical Topics Home Studies I PRESERVE I PRESERVE Disease Heart failure 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 N = 4128 40.0% male 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 105.4/1000 py 105.4 100.4 79.1/1000 py https://web.pathway.md/studies/recI41nO7uSO9gO0X 1/2 6/28/23, 11:31 PM I-PRESERVE Pathway 52.7/1000 py 26.4/1000 py No significant difference 0.0/1000 py Irbesartan Placebo 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. Open reference URL https://web.pathway.md/studies/recI41nO7uSO9gO0X 2/2