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

This study has been terminated.
(Study has been termination early due to financial constraints.)
Sponsor:
Information provided by:
Synvista Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00739687
First received: August 21, 2008
Last updated: January 29, 2009
Last verified: January 2009
History of Changes
  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 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:

U.S. FDA Resources

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
Experimental: ALT-711
Alagebrium 200 mg BID
 Drug: ALT-711
200 mg tablet BID for 9 months.
Other Name: Alagebrium
Experimental: Placebo
Placebo
 Drug: Placebo
200 mg tablet BID for 9 months.
Other Name: Placebo

  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
Birmingham, Alabama, United States, 35294
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, South Carolina
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29403
Sponsors and Collaborators
Synvista Therapeutics, Inc
  More Information

No publications provided

Responsible Party: Adriaan A. Voors, MD, PhD, University Medical Center Groningen, Groningen, The Netherlands
ClinicalTrials.gov Identifier: NCT00739687     History of Changes
Other Study ID Numbers: ALT-711-0527a
Study First Received: August 21, 2008
Last Updated: January 29, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Synvista Therapeutics, Inc:
Chronic Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013