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

This study has been completed.
Sponsor:
Information provided by:
Synvista Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00516646
First received: August 13, 2007
Last updated: January 12, 2010
Last verified: April 2009

August 13, 2007
January 12, 2010
August 2007
August 2009   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00516646 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Heart Failure
  • Drug: ALT-711
    200 mg bid
    Other Name: Alagebrium
  • Drug: Placebo
    bid
    Other Name: Placebo
  • Active Comparator: 1
    ALT-711 200 mg bid
    Intervention: Drug: ALT-711
  • Placebo Comparator: 2
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
October 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00516646
ALT-711-0527
No
A.A. Voors, MD PhD, University Medical Center Groningen, Groningen, The Netherlands
Synvista Therapeutics, Inc
Not Provided
Principal Investigator: Adriaan A Voors, MD, PhD University Medical Centre Groningen
Synvista Therapeutics, Inc
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP