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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
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
U.S. FDA Resources

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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT00662116

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States, 35294
Huntsville, Alabama, United States, 35801
Mobile, Alabama, United States, 36608
United States, California
Anaheim, California, United States
Bakersfield, California, United States, 93308
La Jolla, California, United States, 92037
Roseville, California, United States, 95661
United States, Florida
Jacksonville, Florida, United States, 32209
Miami, Florida, United States, 33136
St. Petersburg, Florida, United States, 33709
United States, Georgia
Covington, Georgia, United States, 30014
United States, Indiana
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Louisville, Kentucky, United States, 40207
United States, Maine
Auburn, Maine, United States, 04210
South Portland, Maine, United States, 04106
United States, Massachusetts
Ayer, Massachusetts, United States, 01432
United States, Nebraska
Lincoln, Nebraska, United States, 68506
United States, New Jersey
Ridgewood, New Jersey, United States, 07450
United States, New York
Albany, New York, United States, 12205
Stonybrook, New York, United States, 11794
United States, North Carolina
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cincinnati, Ohio, United States, 45219
Dayton, Ohio, United States, 45414
Fairfield, Ohio, United States, 45014
Sandusky, Ohio, United States, 44870
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73112
United States, South Carolina
Charleston, South Carolina, United States, 29401
United States, Tennessee
Germantown, Tennessee, United States, 38138
United States, Texas
Lackland Airforce Base, Texas, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Synvista Therapeutics, Inc
Principal Investigator: Bertram Pitt, MD University of Michigan

Responsible Party: Carl Mendel, MD/Chief Medical Officer, Synvista 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