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

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ClinicalTrials.gov Identifier: NCT00662116
Recruitment Status : Terminated (Study has been terminated early due to financial constraints.)
First Posted : April 21, 2008
Last Update Posted : January 30, 2009
Sponsor:
Information provided by:
Synvista Therapeutics, Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Diastolic Heart Failure Drug: alagebrium Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2008
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. QOL as assessed by the Kansas City Cardiomyopathy Questionnaire [ Time Frame: baseline, week 12 and week 24 ]
  2. To assess New York Heart Association Classification [ Time Frame: Baseline, week 12 and week 24 ]
  3. To evaluate cardiovascular death or hospitalization for heart failure [ Time Frame: Will be assessed during the entire 24 wk trial ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT00662116


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

Responsible Party: Carl Mendel, MD/Chief Medical Officer, Synvista
ClinicalTrials.gov Identifier: NCT00662116     History of Changes
Other Study ID Numbers: ALT-711-0530
First Posted: April 21, 2008    Key Record Dates
Last Update Posted: January 30, 2009
Last Verified: January 2009

Keywords provided by Synvista Therapeutics, Inc:
diastolic heart failure

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