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

Sponsored by:	Synvista Therapeutics, Inc
Information provided by:	Synvista Therapeutics, Inc
ClinicalTrials.gov Identifier:	NCT00516646

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 II

MedlinePlus related topics: Heart Failure

Drug Information available for: Alagebrium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Placebo-Controlled, Randomized Trial Evaluating the Efficacy and Safety of Alagebrium (ALT-711) in Patients With Chronic Heart Failure

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
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator ALT-711 200 mg bid	Drug: ALT-711 200 mg bid
2: Placebo Comparator	Drug: Placebo bid

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

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

Contacts

Contact: Carl Mendel, MD	201 934 5000
Contact: Brenda Herrington Herrington	201 934 5000

Locations

Netherlands, P.O. Box 30 001
Dept. Cardiology - University Medical Center Groningen	Recruiting
Groningen, P.O. Box 30 001, Netherlands, 9700 RB
Contact: Anja Branderhorst 0031-(0)50-3612864

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

Little WC, Zile MR, Kitzman DW, Hundley WG, O'Brien TX, Degroof RC. The effect of alagebrium chloride (ALT-711), a novel glucose cross-link breaker, in the treatment of elderly patients with diastolic heart failure. J Card Fail. 2005 Apr;11(3):191-5.

Responsible Party:	University Medical Center Groningen, Groningen, The Netherlands ( A.A. Voors, MD PhD )
Study ID Numbers:	ALT-711-0527
Study First Received:	August 13, 2007
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00516646
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

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009