Journal
EUROPEAN JOURNAL OF HEART FAILURE
Volume 12, Issue 3, Pages 294-300Publisher
WILEY
DOI: 10.1093/eurjhf/hfp207
Keywords
Heart failure; Advanced glycation end-products; AGE breaker
Categories
Funding
- Synvista Therapeutics, Montvale, NJ, USA
- Netherlands Heart Foundation [D97-017, 2006T37, 2006T012]
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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. 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 VO2 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. 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.
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