drugset / Trial / NCT00516646
The BENEFICIAL Study: Evaluating the Efficacy and Safety of Alagebrium (ALT-711) in Patients With Chronic Heart Failure
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Several lines of evidence have suggested that Advanced Glycation End-products (AGEs) play a role in the development and progression of heart failure. The AGE-crosslink breaker Alagebrium (ALT-711) improved cardiac function and symptoms in experimental and small human heart failure studies. These results have not yet been confirmed in a randomized controlled clinical trial.
Timeline
- Start
- 2007-08
- Primary completion
- 2009-08
- Completion
- 2009-10
Publications
- Background Thohan V, Koerner MM, Pratt CM, Torre GA. Improvements in Diastolic Function Among Patients with Advanced Systolic Heart Failure Utilizing Alagebrium (an Oral Advanced Glycation End-product Cross-link Breaker). American Heart Association Scientific Sessions . 2005. Ref Type: Abstract
- Background Little WC, Zile MR, Kitzman DW, Hundley WG, O'Brien TX, Degroof RC. The effect of alagebrium chloride (ALT-711), a novel glucose cross-link breaker, in the treatment of elderly patients with diastolic heart failure. J Card Fail. 2005 Apr;11(3):191-5. doi: 10.1016/j.cardfail.2004.09.010.
- Hartog JW, Willemsen S, van Veldhuisen DJ, Posma JL, van Wijk LM, Hummel YM, Hillege HL, Voors AA; BENEFICIAL investigators. Effects of alagebrium, an advanced glycation endproduct breaker, on exercise tolerance and cardiac function in patients with chronic heart failure. Eur J Heart Fail. 2011 Aug;13(8):899-908. doi: 10.1093/eurjhf/hfr067. Epub 2011 Jun 13.
- Willemsen S, Hartog JW, Hummel YM, Posma JL, van Wijk LM, van Veldhuisen DJ, Voors AA. 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. 2010 Mar;12(3):294-300. doi: 10.1093/eurjhf/hfp207. Epub 2010 Jan 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | alagebrium | Small molecule | 200 mg | — |