Effects of alagebrium, an advanced glycation end-product breaker, in patients with chronic heart failure: study design and baseline characteristics of the BENEFICIAL trial.
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.
Willemsen
Suzan
S
Department of Cardiology, University Medical Center Groningen, University of Groningen, PO Box 30.001, 9700 RB Groningen, The Netherlands.
Hartog
Jasper W L
JW
Hummel
Yoran M
YM
Posma
Jan L
JL
van Wijk
Leen M
LM
van Veldhuisen
Dirk J
DJ
Voors
Adriaan A
AA
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
D017127:Glycation End Products, Advanced; D013844:Thiazoles; C406794:alagebrium