| Effects of alagebrium, an advanced glycation end-product breaker, in patients with chronic heart failure: study design and baseline characteristics of the BENEFICIAL trial. | |
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MedLine Citation:
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PMID: 20100811 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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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:
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Title: European journal of heart failure Volume: 12 ISSN: 1879-0844 ISO Abbreviation: Eur. J. Heart Fail. Publication Date: 2010 Mar |
Date Detail:
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Created Date: 2010-02-16 Completed Date: 2010-06-10 Revised Date: 2011-06-08 |
Medline Journal Info:
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Nlm Unique ID: 100887595 Medline TA: Eur J Heart Fail Country: Netherlands |
Other Details:
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Languages: eng Pagination: 294-300 Citation Subset: IM |
Affiliation:
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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.:
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ClinicalTrials.gov/NCT00516646 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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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:
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0/ALT 711; 0/Glycosylation End Products, Advanced; 0/Thiazoles |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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