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Effects of alagebrium, an advanced glycation end‐product breaker, in patients with chronic heart failure: study design and baseline characteristics of the BENEFICIAL trial
Author(s) -
Willemsen Suzan,
Hartog Jasper W.L.,
Hummel Yoran M.,
Posma Jan L.,
Wijk Leen M.,
Veldhuisen Dirk J.,
Voors Adriaan A.
Publication year - 2010
Publication title -
european journal of heart failure
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.149
H-Index - 133
eISSN - 1879-0844
pISSN - 1388-9842
DOI - 10.1093/eurjhf/hfp207
Subject(s) - medicine , heart failure , advanced glycation end product , cardiology , baseline (sea) , glycation , clinical trial , receptor , oceanography , geology
Aims Previous small open label studies have shown that the advanced glycation end‐product (AGE) breaker alagebrium may improve cardiac function in patients with chronic heart failure (HF). We report the design, methods and baseline characteristics of a double‐blind, placebo‐controlled, randomized trial evaluating the efficacy and safety of alagebrium (BENEFICIAL) in patients with HF and a left ventricular ejection fraction (LVEF) ≤ 0.45. Methods and results Patients with NYHA II–IV stable HF for at least 3 months were eligible for this study. One hundred and two patients were included in the study and randomized to either 200 mg alagebrium twice daily or placebo for a period of 36 weeks. The mean age of patients was 60 ± 11 years, 78% were male, and 17% were diabetic. Mean peak VO 2 was 21.7 ± 5.9 mL/min/kg, mean LVEF was 0.32 ± 0.09. Diastolic function was worse (mean early tissue diastolic velocity ( E ′) 4.6 ± 1.7 vs. 6.1 ± 2.0 cm/s; P < 0.001) in patients with LVEF ≤ 0.35 compared to patients with LVEF between 0.35 and 0.45. Conclusion The BENEFICIAL study is a proof‐of‐concept study that will provide new data on the efficacy and safety of the AGE crosslink breaker alagebrium in systolic HF patients. EudraCT number of this trial is NCT00516646.