© 2008 European Society of Cardiology
Heart failure with preserved ejection fraction: Clinical characteristics of 4133 patients enrolled in the I-PRESERVE trial
a Department of Cardiology, Western Infirmary, Glasgow, and Faculty of Medicine, University of Glasgow Scotland, UK
b Washington Veterans Affairs Medical Center and Georgetown University Washington DC, USA
c University Pierre et Marie Curie Paris 6; Hôpital Pitiê-Salpêtrière Paris, France
d McMaster University Hamilton ON, Canada
e Medical University of South Carolina and Veterans' Affairs Medical Center Charleston SC, USA
f Pharmaceutical Research Institute, Bristol Myers Squibb Princeton NJ, USA
g Sanofi-Aventis Bridgewater, New Jersey, USA
h University of California and San Francisco Veterans Affairs Medical Center San Francisco CA, USA
* Corresponding author. BHF Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, Scotland, UK. Tel.: +44 141 330 3479; fax: +44 141 330 6955. E-mail address: j.mcmurray{at}bio.gla.ac.uk (J.J.V. McMurray).
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Abstract |
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Background: We describe the baseline characteristics of subjects randomised in the largest placebo-controlled, morbidity-mortality trial to date in patients with heart failure and preserved ejection fraction — the irbesartan in heart failure with preserved systolic function trial (I-PRESERVE).
Methods and results: 4133 patients with a mean age of 72 years (a third were 75 years or older) were randomised and 60% were women. The mean (SD) LVEF was 59 (9)% and almost 80% of patients were in NYHA Class III or IV. Approximately 80% of patients were also overweight or obese. Heart failure was reported by investigators to have a hypertensive aetiology in 64% of patients. Prior myocardial infarction was relatively uncommon (24%), as was coronary revascularisation (13%). Atrial fibrillation and diabetes each occurred in between a quarter and a third of patients. The following treatments were used at baseline: diuretic 83%, beta-blocker 59%, calcium channel blocker 40%, ACE inhibitor 25%, spironolactone 15% and digoxin 14%.
Conclusions: Patients in I-PRESERVE are broadly representative of those seen in epidemiological studies and, because of this, the results of this trial should be generally applicable to "real world" patients with heart failure and preserved ejection fraction.
Key Words: Heart failure • Diastolic heart failure • Clinical trial • Ejection fraction • Epidemiology
Received October 23, 2007; Revised December 5, 2007; Accepted December 19, 2007
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