Safety & Efficacy of ALT-711 (Alagebrium) in Chronic Heart Failure (BENEFICIAL)
January 29, 2009 updated by: Synvista Therapeutics, Inc
A Double-Blind, Placebo-Controlled, Randomized Trial Evaluating the Efficacy and Safety of Alagebrium (ALT-711) in Patients With Chronic Heart Failure
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- University of Alabama Hospital
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Henry Ford Hospital
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
-
-
South Carolina
-
Charleston, South Carolina, United States, 29403
- Medical University of South Carolina (MUSC)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Placebo
|
200 mg tablet BID for 9 months.
|
|
Experimental: ALT-711
Alagebrium 200 mg BID
|
200 mg tablet BID for 9 months.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Anticipated)
August 1, 2009
Study Completion (Anticipated)
October 1, 2009
Study Registration Dates
First Submitted
August 21, 2008
First Submitted That Met QC Criteria
August 21, 2008
First Posted (Estimate)
August 22, 2008
Study Record Updates
Last Update Posted (Estimate)
January 30, 2009
Last Update Submitted That Met QC Criteria
January 29, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALT-711-0527a
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.