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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00516646
Recruitment Status : Completed
First Posted : August 15, 2007
Last Update Posted : January 13, 2010
Information provided by:
Synvista Therapeutics, Inc

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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: ALT-711 Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: 1
ALT-711 200 mg bid
Drug: ALT-711
200 mg bid
Other Name: Alagebrium

Placebo Comparator: 2 Drug: Placebo

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00516646

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

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: A.A. Voors, MD PhD, University Medical Center Groningen, Groningen, The Netherlands Identifier: NCT00516646     History of Changes
Other Study ID Numbers: ALT-711-0527
First Posted: August 15, 2007    Key Record Dates
Last Update Posted: January 13, 2010
Last Verified: April 2009

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases