Effects of alagebrium, an advanced glycation end-product breaker, in patients with chronic heart failure: study design and baseline characteristics of the BENEFICIAL trial.
Eur J Heart Fail
; 12(3): 294-300, 2010 Mar.
Article
en En
| MEDLINE
| ID: mdl-20100811
ABSTRACT
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)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 LVEFCONCLUSION:
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.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Tiazoles
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Productos Finales de Glicación Avanzada
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Insuficiencia Cardíaca
Tipo de estudio:
Clinical_trials
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Etiology_studies
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Risk_factors_studies
Límite:
Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Eur J Heart Fail
Asunto de la revista:
CARDIOLOGIA
Año:
2010
Tipo del documento:
Article
País de afiliación:
Países Bajos