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
  Purpose

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.


Condition Intervention Phase
Heart Failure
Drug: ALT-711
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Randomized Trial Evaluating the Efficacy and Safety of Alagebrium (ALT-711) in Patients With Chronic Heart Failure

Resource links provided by NLM:


Further study details as provided by Synvista Therapeutics, Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: August 2007
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
ALT-711 200 mg bid
Drug: ALT-711
200 mg bid
Other Name: Alagebrium
Placebo Comparator: 2 Drug: Placebo
bid
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516646

Locations
Netherlands
Dept. Cardiology - University Medical Center Groningen
Groningen, P.O. Box 30 001, Netherlands, 9700 RB
Sponsors and Collaborators
Synvista Therapeutics, Inc
Investigators
Principal Investigator: Adriaan A Voors, MD, PhD University Medical Centre Groningen
  More Information

Publications:
Thohan V, Koerner MM, Pratt CM, Torre GA. Improvements in Diastolic Function Among Patients with Advanced Systolic Heart Failure Utilizing Alagebrium (an Oral Advanced Glycation End-product Cross-link Breaker). American Heart Association Scientific Sessions . 2005. Ref Type: Abstract

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: A.A. Voors, MD PhD, University Medical Center Groningen, Groningen, The Netherlands
ClinicalTrials.gov Identifier: NCT00516646     History of Changes
Other Study ID Numbers: ALT-711-0527
Study First Received: August 13, 2007
Last Updated: January 12, 2010
Health Authority: Netherlands: Medicines Evaluation Board (MEB)
United States: Food and Drug Administration

Keywords provided by Synvista Therapeutics, Inc:
Advanced Glycation End-products (AGEs)
Alegebrium

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 25, 2014