Safety & Efficacy of ALT-711 (Alagebrium) in Chronic Heart Failure
NCT ID: NCT00739687
Last Updated: 2009-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
100 participants
INTERVENTIONAL
2008-08-31
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ALT-711
Alagebrium 200 mg BID
ALT-711
200 mg tablet BID for 9 months.
Placebo
Placebo
Placebo
200 mg tablet BID for 9 months.
Interventions
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ALT-711
200 mg tablet BID for 9 months.
Placebo
200 mg tablet BID for 9 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Synvista Therapeutics, Inc
INDUSTRY
Responsible Party
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University Medical Center Groningen, Groningen, The Netherlands
Locations
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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
Countries
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Other Identifiers
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ALT-711-0527a
Identifier Type: -
Identifier Source: org_study_id