Cited by 1,960Heart Failure Treatment and ManagementCardiovascular Function and Risk FactorsBlood Pressure and Hypertension Studies

Irbesartan in patients with heart failure and preserved ejection fraction

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Massie, Barry M., Carson, Peter E., McMurray, John J., Komajda, Michel, McKelvie, Robert, Zile, Michael R., Anderson, Susan, Donovan, Mark +3 more·2008·New England Journal of Medicine

Abstract

BACKGROUND: Approximately 50% of patients with heart failure have a left ventricular ejection fraction of at least 45%, but no therapies have been shown to improve the outcome of these patients. Therefore, we studied the effects of irbesartan in patients with this syndrome. METHODS: We enrolled 4128 patients who were at least 60 years of age and had New York Heart Association class II, III, or IV heart failure and an ejection fraction of at least 45% and randomly assigned them to receive 300 mg of irbesartan or placebo per day. The primary composite outcome was death from any cause or hospitalization for a cardiovascular cause (heart failure, myocardial infarction, unstable angina, arrhythmia, or stroke). Secondary outcomes included death from heart failure or hospitalization for heart failure, death from any cause and from cardiovascular causes, and quality of life. RESULTS: During a mean follow-up of 49.5 months, the primary outcome occurred in 742 patients in the irbesartan group and 763 in the placebo group. Primary event rates in the irbesartan and placebo groups were 100.4 and 105.4 per 1000 patient-years, respectively (hazard ratio, 0.95; 95% confidence interval [CI], 0.86 to 1.05; P=0.35). Overall rates of death were 52.6 and 52.3 per 1000 patient-years, respectively (hazard ratio, 1.00; 95% CI, 0.88 to 1.14; P=0.98). Rates of hospitalization for cardiovascular causes that contributed to the primary outcome were 70.6 and 74.3 per 1000 patient-years, respectively (hazard ratio, 0.95; 95% CI, 0.85 to 1.08; P=0.44). There were no significant differences in the other prespecified outcomes. CONCLUSIONS: Irbesartan did not improve the outcomes of patients with heart failure and a preserved left ventricular ejection fraction. (ClinicalTrials.gov number, NCT00095238.)

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  1. Desai A. Current understanding of 10. heart failure with preserved ejection frac- tion. Curr Opin Cardiol 2007;22:578-85.

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Authors
Massie, B. M., Carson, P. E., McMurray, J. J., Komajda, M., McKelvie, R., Zile, M. R., Anderson, S., Donovan, M., Iverson, E., Staiger, C., & Ptaszynska, A.
Affiliations
  • San Francisco VA Medical Center (US)
  • Georgetown University (US)
  • University of Glasgow (GB)
  • Hamilton Health Sciences (CA)
  • Medical University of South Carolina (US)
  • University of Wisconsin–Madison (US)
  • Bristol-Myers Squibb (United States) (US)
  • Sanofi (United States) (US)
Venue
New England Journal of Medicine
Published
2008-12-04
Volume
359
Issue
23
Pages
2456-2467
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2068519950
Cited by
1,960
References
37
Citations by year
2026: 61 · 2025: 72 · 2024: 92 · 2023: 94 · 2022: 128 · 2021: 120 · 2020: 123 · 2019: 118 · 2018: 117 · 2017: 138 · 2016: 105 · 2015: 127 · 2014: 119 · 2013: 122 · 2012: 109
FWCI
75.20
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • Ghent University Academic Bibliography (Ghent University) (submittedVersion)
  • University of Debrecen Electronic Archive (University of Debrecen) (submittedVersion, other-oa)
  • IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
  • Use Siena air (University of Siena) (submittedVersion)
Topics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Function and Risk Factors
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
Keywords
irbesartan, heart failure with preserved ejection fraction, angiotensin receptor blockers, cardiovascular mortality, cardiovascular hospitalization, heart failure hospitalization, quality of life, elderly patients
MeSH terms
Irbesartan, Adrenergic beta-Antagonists, Aged, Angiotensin-Converting Enzyme Inhibitors, Biphenyl Compounds, Cardiovascular Diseases, Drug Therapy, Combination, Female, Follow-Up Studies, Heart Failure, Hospitalization, Humans, Male, Middle Aged, Quality of Life, Stroke Volume, Tetrazoles, Proportional Hazards Models, Treatment Failure, Angiotensin II Type 1 Receptor Blockers, Kaplan-Meier Estimate

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