The BENEFICIAL Study: Evaluating the Efficacy and Safety of Alagebrium (ALT-711) in Patients With Chronic Heart Failure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Double-blind, Placebo-controlled, Randomized Trial Evaluating the Efficacy and Safety of Alagebrium (ALT-711) in Patients With Chronic Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: ALT-711
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>ALT-711 200 mg bid | Drug: ALT-711<br>* 200 mg bid<br>* Other names: Alagebrium;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* bid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end-point of the study will be aerobic capacity (VO2max) measured at exercise testing |  | At baseline and after 9 months of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | At baseline and after 9 months of study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Glycation End-products (AGEs), Alegebrium