Status:
TERMINATED
Safety & Efficacy of ALT-711 (Alagebrium) in Chronic Heart Failure
Lead Sponsor:
Synvista Therapeutics, Inc
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 card...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00739687
Start Date
August 1 2008
End Date
October 1 2009
Last Update
January 30 2009
Active Locations (4)
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1
University of Alabama Hospital
Birmingham, Alabama, United States, 35294
2
Henry Ford Hospital
Detroit, Michigan, United States, 48202
3
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
4
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29403