Beginning a Randomized Evaluation of the AGE Breaker Alagebrium in Diastolic Heart Failure (BREAK-DHF-I)

This study has been terminated.
(Study has been terminated early due to financial constraints.)
Sponsor:
Information provided by:
Synvista Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00662116
First received: April 17, 2008
Last updated: January 29, 2009
Last verified: January 2009
  Purpose

This study is being done to evaluate the safety and effectiveness of alagebrium in subjects diagnosed with diastolic heart failure. The primary assessment for effectiveness is the assessment of exercise tolerance.


Condition Intervention Phase
Diastolic Heart Failure
Drug: alagebrium
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Effects of Alagebrium on Exercise in Subjects With Diastolic Heart Failure

Resource links provided by NLM:


Further study details as provided by Synvista Therapeutics, Inc:

Primary Outcome Measures:
  • The primary efficacy measure will be exercise tolerance as assessed utilizing the 6 Minute Walk Test [ Time Frame: Assessed at baseline, week 12 and week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • QOL as assessed by the Kansas City Cardiomyopathy Questionnaire [ Time Frame: baseline, week 12 and week 24 ] [ Designated as safety issue: No ]
  • To assess New York Heart Association Classification [ Time Frame: Baseline, week 12 and week 24 ] [ Designated as safety issue: No ]
  • To evaluate cardiovascular death or hospitalization for heart failure [ Time Frame: Will be assessed during the entire 24 wk trial ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: March 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: alagebrium
200 mg (two 100 mg tablets) two times daily for 24 weeks
Other Name: ALT-711
Placebo Comparator: 2 Drug: placebo
placebo tablets - two tablets taken twice daily
Other Name: placebo

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of diabetes or hypertension requiring therapy
  • EF >/= 45% via echo within 1 year and evidence of diastolic heart failure via echo measurement of E/E'>/= 12 determined by echo within 1 year
  • previous hospitalization for heart failure or previous BNP >100 pg/mL.

Exclusion Criteria:

  • Clinically significant valvular disease
  • history of stroke/TIA or reversible ischemic neurological defect w/i 6 mths
  • history of acute MI within 6 months
  • severe COPD
  • active or treated malignancies (except basal cell carcinoma)
  • significant systemic illnesses that would prohibit completion of the study or compliance
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662116

  Show 30 Study Locations
Sponsors and Collaborators
Synvista Therapeutics, Inc
Investigators
Principal Investigator: Bertram Pitt, MD University of Michigan
  More Information

No publications provided

Responsible Party: Carl Mendel, MD/Chief Medical Officer, Synvista
ClinicalTrials.gov Identifier: NCT00662116     History of Changes
Other Study ID Numbers: ALT-711-0530
Study First Received: April 17, 2008
Last Updated: January 29, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Synvista Therapeutics, Inc:
diastolic heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 29, 2014