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Completed

NCT Number: NCT00516646

The BENEFICIAL Study: 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 (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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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dept. Cardiology - University Medical Center Groningen

Groningen, P.O. Box 30 001, 9700 RB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alt-711

Drug

200 mg bid

Other names: Alagebrium

Placebo

Drug

bid

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Synvista Therapeutics, Inc

Industry

Registry information

Official study title

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

Acronym: BENEFICIAL

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 15, 2007
Registry last updated
Jan 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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