Safety & Efficacy of ALT-711 (Alagebrium) in Chronic Heart Failure
Status:
Terminated
Trial end date:
2009-10-01
Target enrollment:
Participant gender:
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 improved cardiac function and symptoms in experimental preclinical and small human
heart failure studies. These results have not yet been confirmed in a randomized controlled
clinical trial. Objective: to evaluate the safety and efficacy of alagebrium in subjects
diagnosed with heart failure. This is a randomized, double-blind, placebo-controlled trial to
assess the effects of 400 mg (2 x 100 mg bid) of alagebrium versus placebo over 9 months. 100
subjects will be studied (50 per treatment group) in approximately 6 centers. Procedures:
exercise testing (VO2 max; the primary variable), ECGs and blood sampling.