title: Effects of alagebrium, an advanced glycation end-product breaker, in patients with chronic heart failure: study design and baseline characteristics of the BENEFICIAL trial.
abstract: OBJECTIVE
  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.
  
  
  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 <or= 0.35 compared to patients with LVEF between 0.35 and 0.45.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Cardiology, University Medical Center Groningen, University of Groningen, PO Box 30.001, 9700 RB Groningen, The Netherlands.
authors.forename: Suzan
authors.initials: S
authors.lastname: Willemsen
authors.forename: Jasper W L
authors.initials: JW
authors.lastname: Hartog
authors.forename: Yoran M
authors.initials: YM
authors.lastname: Hummel
authors.forename: Jan L
authors.initials: JL
authors.lastname: Posma
authors.forename: Leen M
authors.initials: LM
authors.lastname: van Wijk
authors.forename: Dirk J
authors.initials: DJ
authors.lastname: van Veldhuisen
authors.forename: Adriaan A
authors.initials: AA
authors.lastname: Voors
mesh_terms: D003971:Diastole; D004311:Double-Blind Method; D025401:Echocardiography, Stress; D005080:Exercise Test; D017079:Exercise Tolerance; D005260:Female; D017127:Glycation End Products, Advanced / Q000037:antagonists & inhibitors*; D006305:Health Status Indicators; D006333:Heart Failure / Q000000981:diagnostic imaging / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010101:Oxygen Consumption; D012107:Research Design; D013318:Stroke Volume; D011795:Surveys and Questionnaires; D013599:Systole; D013844:Thiazoles / Q000627:therapeutic use*; D016277:Ventricular Function, Left
chemical_list: D017127:Glycation End Products, Advanced; D013844:Thiazoles; C406794:alagebrium