The BENEFICIAL Study: Evaluating the Efficacy and Safety of Alagebrium (ALT-711) in Patients With Chronic Heart Failure
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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 (ALT-711) improved cardiac function and symptoms in experimental and small human heart failure studies. These results have not yet been confirmed in a randomized controlled clinical trial.
Condition | Intervention | Phase |
---|---|---|
Heart Failure |
Drug: ALT-711 Drug: Placebo |
Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Official Title: | A Double-blind, Placebo-controlled, Randomized Trial Evaluating the Efficacy and Safety of Alagebrium (ALT-711) in Patients With Chronic Heart Failure |
- The primary end-point of the study will be aerobic capacity (VO2max) measured at exercise testing [ Time Frame: At baseline and after 9 months of study drug ] [ Designated as safety issue: No ]
- Changes in systolic function, diastolic function, advanced glycation end-products (AGE) measurements, changes in Minnesota Living with Heart Failure score, NYHA heart failure score, patient's and physician's global assessment, and NT-pro-BNP [ Time Frame: At baseline and after 9 months of study drug ] [ Designated as safety issue: No ]
Estimated Enrollment: | 100 |
Study Start Date: | August 2007 |
Study Completion Date: | October 2009 |
Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Active Comparator: 1
ALT-711 200 mg bid
|
Drug: ALT-711
200 mg bid
Other Name: Alagebrium
|
Placebo Comparator: 2 |
Drug: Placebo
bid
Other Name: Placebo
|
Detailed Description:
This study is a double-blind, randomized, placebo-controlled, parallel design trial enrolling 100 patients (2x50) with stable CHF. Patients will be randomized to either 200 mg Alagebrium twice daily or placebo for a period of 9 months. Efficacy measurements will be performed at baseline, and at the end of the study, and include aerobic capacity (VO2max) exercise testing, echocardiography, Minnesota Living with Heart Failure score, AGEs measurements in blood and skin, NYHA heart failure class, patient's and physician's global assessment, and levels of NT-pro-BNP. Safety visits are performed at 3 months intervals. In addition, one safety visit will be performed 2 weeks after the randomization visit and 1 month after the last treatment visit. A total of 8 visits will be performed during the entire study.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- NYHA II-IV heart failure
- Echocardiographic ejection fraction ≤ 40%
- Duration of heart failure > 3 months
- Stable heart failure medical therapy for > 1 months
Exclusion Criteria:
- History of myocardial infarction in previous 6 months
- History of stroke in previous 6 months
- Clinically significant renal, liver, pulmonary,or hematological disease
- Active and or treated malignancies within 12 months
- Uncontrolled diabetes mellitus
Netherlands | |
Dept. Cardiology - University Medical Center Groningen | |
Groningen, P.O. Box 30 001, Netherlands, 9700 RB |
Principal Investigator: | Adriaan A Voors, MD, PhD | University Medical Centre Groningen |
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | A.A. Voors, MD PhD, University Medical Center Groningen, Groningen, The Netherlands |
ClinicalTrials.gov Identifier: | NCT00516646 History of Changes |
Other Study ID Numbers: | ALT-711-0527 |
Study First Received: | August 13, 2007 |
Last Updated: | January 12, 2010 |
Health Authority: | Netherlands: Medicines Evaluation Board (MEB) United States: Food and Drug Administration |
Keywords provided by Synvista Therapeutics, Inc:
Advanced Glycation End-products (AGEs) Alegebrium |
Additional relevant MeSH terms:
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on October 17, 2012