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

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ClinicalTrials.gov Identifier: NCT00739687
Recruitment Status : Terminated (Study has been termination early due to financial constraints.)
First Posted : August 22, 2008
Last Update Posted : January 30, 2009
Sponsor:
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 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 or disease Intervention/treatment Phase
Chronic Heart Failure Drug: ALT-711 Drug: Placebo Phase 2

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 2008
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 22, 2008    Key Record Dates
Last Update Posted: January 30, 2009
Last Verified: January 2009

Keywords provided by Synvista Therapeutics, Inc:
Chronic Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases