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

January 29, 2009 updated by: Synvista Therapeutics, Inc

A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Effects of Alagebrium on Exercise in Subjects With Diastolic Heart Failure

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: alagebrium
200 mg (two 100 mg tablets) two times daily for 24 weeks
Other Names:
  • ALT-711
Placebo Comparator: 2
Drug: placebo
placebo tablets - two tablets taken twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Assessed at baseline, week 12 and week 24

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synvista Therapeutics, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Anticipated)

October 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

April 17, 2008

First Submitted That Met QC Criteria

April 17, 2008

First Posted (Estimate)

April 21, 2008

Study Record Updates

Last Update Posted (Estimate)

January 30, 2009

Last Update Submitted That Met QC Criteria

January 29, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALT-711-0530

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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