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Safety & Efficacy of ALT-711 (Alagebrium) in Chronic Heart Failure (BENEFICIAL)

This study is currently recruiting participants.
Verified by Synvista Therapeutics, Inc, September 2008

Sponsored by: Synvista Therapeutics, Inc
Information provided by: Synvista Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT00739687
  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 improved cardiac function and symptoms in experimental preclinical and small human heart failure studies. These results have not yet been confirmed in a randomized controlled clinical trial. Objective: to evaluate the safety and efficacy of alagebrium in subjects diagnosed with heart failure. This is a randomized, double-blind, placebo-controlled trial to assess the effects of 400 mg (2 x 100 mg bid) of alagebrium versus placebo over 9 months. 100 subjects will be studied (50 per treatment group) in approximately 6 centers. Procedures: exercise testing (VO2 max; the primary variable), ECGs and blood sampling.


Condition Intervention Phase
Chronic Heart Failure
Drug: ALT-711
Drug: Placebo
Phase II

MedlinePlus related topics:   Heart Failure   

ChemIDplus related topics:   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 (VO2 max) measured at exercise testing. An improvement of 15% in VO2 max will be considered as a clinically significant increase. [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment:   100
Study Start Date:   August 2008
Estimated Study Completion Date:   October 2009
Estimated Primary Completion Date:   August 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
ALT-711: Experimental
Alagebrium 200 mg BID
Drug: ALT-711
200 mg tablet BID for 9 months.
Placebo: Experimental
Placebo
Drug: Placebo
200 mg tablet BID for 9 months.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • NYHA II-IV heart failure
  • Echocardiographic ejection fraction ≤ 45% (echo does not need to be repeated at the screening visit if a prior echo is on record which indicates an ejection fraction < 40%)
  • Duration of heart failure > 3 months
  • Stable heart failure medical therapy for > 1 month
  • Patients need to be able to understand content of and willing to provide informed consent

Exclusion Criteria:

  • Patient ≤ 18 years
  • History of myocardial infarction in previous 6 months
  • History of stroke/TIA/RIND in previous 6 months
  • Severe valvular dysfunction
  • Severe pulmonary disease
  • History of systemic inflammatory or collagen vascular disease
  • Active and or treated malignancies within 12 months prior to inclusion
  • Any significant condition either medical or non-medical that could lead to difficulty complying with the protocol
  • Patients on cardiac resynchronisation therapy (CRT) or scheduled for CRT implantation
  • Pacemaker therapy (unless rescue pacing at ≤ 40 bpm) or scheduled pacemaker implantation
  • History of valve replacement or surgery
  • Uncontrolled diabetes mellitus (HbA1c > 9.5%)
  • Clinically significant renal disturbance (sMDRD calculated GFR≤30 mL/min/1.73m2; sMDRD is calculated as 186 x serum Cr (mg/dl)-1.154 x years-0.203 x (0.742 if female) x (1.210 if African American)
  • Clinically significant liver disease (ASAT/ALAT > 2,5 times the upper limit of normal)
  • Severe anemia at baseline (Hemoglobin <10 g/dl or <6.2 mmol/l)
  • Use of any investigational drug(s) within 30 days prior to screening
  • Pregnancy or active breast-feeding (urine pregnancy tests will be performed on all female subjects of childbearing potential)*
  • Active pericarditis/myocarditis
  • The inability of patients to undergo exercise testing
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739687

Locations
United States, Alabama
University of Alabama Hospital     Recruiting
      Birmingham, Alabama, United States, 35294
      Contact: Robert C. Bourge, M.D.     205-934-3438        
      Sub-Investigator: Barry K. Rayburn, M.D.            
United States, Michigan
Henry Ford Hospital     Recruiting
      Detroit, Michigan, United States, 48202
      Contact: David Lanfear, M.D.     313-972-1920        
United States, North Carolina
Wake Forest University Health Sciences     Not yet recruiting
      Winston-Salem, North Carolina, United States, 27157
      Contact: Dalane W. Kitzman, M.D.     336-716-3274        
United States, South Carolina
Medical University of South Carolina (MUSC)     Recruiting
      Charleston, South Carolina, United States, 29403
      Contact: Adrian Van Bakel, MD     843-876-4790        
      Principal Investigator: Adrian Van Bakel, MD            

Sponsors and Collaborators
Synvista Therapeutics, Inc
  More Information


Responsible Party:   University Medical Center Groningen, Groningen, The Netherlands ( Adriaan A. Voors, MD, PhD )
Study ID Numbers:   ALT-711-0527a
First Received:   August 21, 2008
Last Updated:   September 17, 2008
ClinicalTrials.gov Identifier:   NCT00739687
Health Authority:   United States: Food and Drug Administration

Keywords provided by Synvista Therapeutics, Inc:
Chronic Heart Failure  

Study placed in the following topic categories:
Heart Failure
Heart Diseases

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 15, 2008




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