A Double-Blind, Placebo-Controlled, Randomized Trial Evaluating the Efficacy and Safety of Alagebrium (ALT-711) in Patients With Chronic Heart Failure
Overview
- Phase
- Phase 2
- Intervention
- ALT-711
- Conditions
- Chronic Heart Failure
- Sponsor
- Synvista Therapeutics, Inc
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- The primary end-point of the study will be aerobic capacity (VO2 max) measured at exercise testing. An improvement of 15% in VO2 max will be considered as a clinically significant increase.
- Status
- Terminated
- Last Updated
- 17 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •NYHA II-IV heart failure
- •Echocardiographic ejection fraction ≤ 45% (echo does not need to be repeated at the screening visit if a prior echo is on record which indicates an ejection fraction \< 40%)
- •Duration of heart failure \> 3 months
- •Stable heart failure medical therapy for \> 1 month
- •Patients need to be able to understand content of and willing to provide informed consent
Exclusion Criteria
- •Patient ≤ 18 years
- •History of myocardial infarction in previous 6 months
- •History of stroke/TIA/RIND in previous 6 months
- •Severe valvular dysfunction
- •Severe pulmonary disease
- •History of systemic inflammatory or collagen vascular disease
- •Active and or treated malignancies within 12 months prior to inclusion
- •Any significant condition either medical or non-medical that could lead to difficulty complying with the protocol
- •Patients on cardiac resynchronisation therapy (CRT) or scheduled for CRT implantation
- •Pacemaker therapy (unless rescue pacing at ≤ 40 bpm) or scheduled pacemaker implantation
Arms & Interventions
ALT-711
Alagebrium 200 mg BID
Intervention: ALT-711
Placebo
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
The primary end-point of the study will be aerobic capacity (VO2 max) measured at exercise testing. An improvement of 15% in VO2 max will be considered as a clinically significant increase.
Time Frame: 9 months