Effects of alagebrium, an advanced glycation end-product breaker, in patients with chronic heart failure: study design and baseline characteristics of the BENEFICIAL trial

European Journal of Heart Failure
Suzan WillemsenAdriaan A Voors

Abstract

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) <or= 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 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 <or= 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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Citations

Feb 9, 2012·Cardiology in Review·Anand PrasadSotirios Tsimikas
Dec 14, 2011·Science Translational Medicine·John HuynhCynthia A Reinhart-King
Jan 25, 2011·Heart Failure Reviews·Suzan WillemsenAdriaan A Voors
Sep 9, 2015·European Journal of Heart Failure·Ekaterina S OvchinnikovaEugene Berezikov
Aug 18, 2012·European Journal of Heart Failure·B Daan WestenbrinkPeter van der Meer
Jun 15, 2011·European Journal of Heart Failure·Jasper W L HartogUNKNOWN BENEFICIAL investigators
May 23, 2014·Diabetes/metabolism Research and Reviews·Hang HuChunmao Han
Sep 24, 2015·Research in Cardiovascular Medicine·Antonio NennaCristiano Spadaccio
Apr 29, 2014·International Journal of Cardiology·Cristina EnjuanesJosep Comín-Colet
Jul 7, 2015·Tetrahedron Letters·Mike A RichardsonRandall J Basaraba
Apr 8, 2017·European Journal of Heart Failure·Michał TkaczyszynEwa A Jankowska
Nov 24, 2017·Scientific Reports·Dorien DeluykerVirginie Bito
Jun 28, 2011·Nature Reviews. Drug Discovery·Juan Tamargo, José López-Sendón
May 18, 2010·American Journal of Physiology. Heart and Circulatory Physiology·Begoña LópezJavier Díez
Sep 11, 2010·Expert Review of Cardiovascular Therapy·Ayman El-Menyar, Wael AlMahmeed
Oct 31, 2019·Applied Physiology, Nutrition, and Metabolism = Physiologie Appliquée, Nutrition Et Métabolisme·Ana KovacevicJennifer J Heisz
May 10, 2020·ESC Heart Failure·Eugene S J TanCarolyn S P Lam
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Nov 17, 2020·Frontiers in Psychology·Alexis BullockJennifer J Heisz
May 30, 2021·European Journal of Heart Failure·Michał TkaczyszynEwa A Jankowska

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