The BENEFICIAL Study: Evaluating the Efficacy and Safety of Alagebrium (ALT-711) in Patients With Chronic Heart Failure

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Synvista Therapeutics, Inc

Criteria

Inclusion Criteria:

• NYHA II-IV heart failure

• Echocardiographic ejection fraction ≤ 40%

• Duration of heart failure > 3 months

• Stable heart failure medical therapy for > 1 months

Exclusion Criteria:

• History of myocardial infarction in previous 6 months

• History of stroke in previous 6 months

• Clinically significant renal, liver, pulmonary,or hematological disease

• Active and or treated malignancies within 12 months

• Uncontrolled diabetes mellitus