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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00516646

Acronym

BENEFICIAL

Enrollment

100

Registered

2007-08-15

Start date

2007-08-31

Completion date

2009-10-31

Last updated

2010-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Advanced Glycation End-products (AGEs), Alegebrium

Brief summary

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

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.

Interventions

DRUGALT-711

200 mg bid

DRUGPlacebo

bid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026