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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-10-31

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.

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

ALT-711 200 mg bid

Group Type ACTIVE_COMPARATOR

ALT-711

Intervention Type DRUG

200 mg bid

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

bid

Interventions

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ALT-711

200 mg bid

Intervention Type DRUG

Placebo

bid

Intervention Type DRUG

Other Intervention Names

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Alagebrium

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No