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

Primary Purpose

Diastolic Heart Failure

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
alagebrium
placebo
Sponsored by
Synvista Therapeutics, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diastolic Heart Failure focused on measuring diastolic heart failure

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

The primary efficacy measure will be exercise tolerance as assessed utilizing the 6 Minute Walk Test

Secondary Outcome Measures

QOL as assessed by the Kansas City Cardiomyopathy Questionnaire
To assess New York Heart Association Classification
To evaluate cardiovascular death or hospitalization for heart failure

Full Information

First Posted
April 17, 2008
Last Updated
January 29, 2009
Sponsor
Synvista Therapeutics, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00662116
Brief Title
Beginning a Randomized Evaluation of the AGE Breaker Alagebrium in Diastolic Heart Failure (BREAK-DHF-I)
Acronym
BREAK-DHF-I
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 Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Terminated
Why Stopped
Study has been terminated early due to financial constraints.
Study Start Date
March 2008 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Synvista Therapeutics, Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diastolic Heart Failure
Keywords
diastolic heart failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
alagebrium
Other Intervention Name(s)
ALT-711
Intervention Description
200 mg (two 100 mg tablets) two times daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo tablets - two tablets taken twice daily
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
QOL as assessed by the Kansas City Cardiomyopathy Questionnaire
Time Frame
baseline, week 12 and week 24
Title
To assess New York Heart Association Classification
Time Frame
Baseline, week 12 and week 24
Title
To evaluate cardiovascular death or hospitalization for heart failure
Time Frame
Will be assessed during the entire 24 wk trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertram Pitt, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
City
Anaheim
State/Province
California
Country
United States
City
Bakersfield
State/Province
California
ZIP/Postal Code
93308
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
City
Covington
State/Province
Georgia
ZIP/Postal Code
30014
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
City
South Portland
State/Province
Maine
ZIP/Postal Code
04106
Country
United States
City
Ayer
State/Province
Massachusetts
ZIP/Postal Code
01432
Country
United States
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
City
Stonybrook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
City
Fairfield
State/Province
Ohio
ZIP/Postal Code
45014
Country
United States
City
Sandusky
State/Province
Ohio
ZIP/Postal Code
44870
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
City
Lackland Airforce Base
State/Province
Texas
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

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

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