Safety & Efficacy of ALT-711 (Alagebrium) in Chronic Heart Failure
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Chronic Heart Failure
In brief
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.
Key facts
- Study ID
- NCT00739687
- Run by
- Synvista Therapeutics, Inc
- People needed
- 100
- Starts
- 2008-08-01
- Expected to finish
- 2009-10-01
- Last updated by the study team
- 2009-01-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- History of valve replacement or surgery
- Uncontrolled diabetes mellitus (HbA1c > 9.5%)
- Clinically significant renal disturbance (sMDRD calculated GFR≤30 mL/min/1.73m2; sMDRD is calculated as 186 x serum Cr (mg/dl)-1.154 x years-0.203 x (0.742 if female) x (1.210 if African American)
- Clinically significant liver disease (ASAT/ALAT > 2,5 times the upper limit of normal)
- Severe anemia at baseline (Hemoglobin <10 g/dl or <6.2 mmol/l)
- Use of any investigational drug(s) within 30 days prior to screening
- Pregnancy or active breast-feeding (urine pregnancy tests will be performed on all female subjects of childbearing potential)*
- Active pericarditis/myocarditis
- The inability of patients to undergo exercise testing
Where it is running
- University of Alabama Hospital — Birmingham, Alabama, United States
- Henry Ford Hospital — Detroit, Michigan, United States
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
- Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.