Chronic Heart Failure Clinical Trial
— BENEFICIALOfficial title:
A Double-Blind, Placebo-Controlled, Randomized Trial Evaluating the Efficacy and Safety of Alagebrium (ALT-711) in Patients With Chronic Heart Failure
Verified date | January 2009 |
Source | Synvista Therapeutics, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 100 |
Est. completion date | October 2009 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama Hospital | Birmingham | Alabama |
United States | Medical University of South Carolina (MUSC) | Charleston | South Carolina |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Synvista Therapeutics, Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 9 months | No |
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