Document Detail


Effects of alagebrium, an advanced glycation end-product breaker, in patients with chronic heart failure: study design and baseline characteristics of the BENEFICIAL trial.
MedLine Citation:
PMID:  20100811     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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) <or= 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 <or= 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.
Authors:
Suzan Willemsen; Jasper W L Hartog; Yoran M Hummel; Jan L Posma; Leen M van Wijk; Dirk J van Veldhuisen; Adriaan A Voors
Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-01-25
Journal Detail:
Title:  European journal of heart failure     Volume:  12     ISSN:  1879-0844     ISO Abbreviation:  Eur. J. Heart Fail.     Publication Date:  2010 Mar 
Date Detail:
Created Date:  2010-02-16     Completed Date:  2010-06-10     Revised Date:  2013-05-27    
Medline Journal Info:
Nlm Unique ID:  100887595     Medline TA:  Eur J Heart Fail     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  294-300     Citation Subset:  IM    
Affiliation:
Department of Cardiology, University Medical Center Groningen, University of Groningen, PO Box 30.001, 9700 RB Groningen, The Netherlands.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00516646
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MeSH Terms
Descriptor/Qualifier:
Diastole
Double-Blind Method
Echocardiography, Stress
Exercise Test
Exercise Tolerance
Female
Glycosylation End Products, Advanced / antagonists & inhibitors*
Health Status Indicators
Heart Failure / drug therapy*,  ultrasonography
Humans
Male
Middle Aged
Oxygen Consumption
Questionnaires
Research Design
Stroke Volume
Systole
Thiazoles / therapeutic use*
Ventricular Function, Left
Chemical
Reg. No./Substance:
0/Glycosylation End Products, Advanced; 0/Thiazoles; DGH49JXB1F/alagebrium

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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