Study Stopped
Study has been terminated early due to financial constraints.
Beginning a Randomized Evaluation of the AGE Breaker Alagebrium in Diastolic Heart Failure (BREAK-DHF-I)
BREAK-DHF-I
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Effects of Alagebrium on Exercise in Subjects With Diastolic Heart Failure
1 other identifier
interventional
160
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2008
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 17, 2008
CompletedFirst Posted
Study publicly available on registry
April 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJanuary 30, 2009
January 1, 2009
1.6 years
April 17, 2008
January 29, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary efficacy measure will be exercise tolerance as assessed utilizing the 6 Minute Walk Test
Assessed at baseline, week 12 and week 24
Secondary Outcomes (3)
QOL as assessed by the Kansas City Cardiomyopathy Questionnaire
baseline, week 12 and week 24
To assess New York Heart Association Classification
Baseline, week 12 and week 24
To evaluate cardiovascular death or hospitalization for heart failure
Will be assessed during the entire 24 wk trial
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Unknown Facility
Birmingham, Alabama, 35294, United States
Unknown Facility
Huntsville, Alabama, 35801, United States
Unknown Facility
Mobile, Alabama, 36608, United States
Unknown Facility
Anaheim, California, United States
Unknown Facility
Bakersfield, California, 93308, United States
Unknown Facility
La Jolla, California, 92037, United States
Unknown Facility
Roseville, California, 95661, United States
Unknown Facility
Jacksonville, Florida, 32209, United States
Unknown Facility
Miami, Florida, 33136, United States
Unknown Facility
St. Petersburg, Florida, 33709, United States
Unknown Facility
Covington, Georgia, 30014, United States
Unknown Facility
Indianapolis, Indiana, 46260, United States
Unknown Facility
Louisville, Kentucky, 40207, United States
Unknown Facility
Auburn, Maine, 04210, United States
Unknown Facility
South Portland, Maine, 04106, United States
Unknown Facility
Ayer, Massachusetts, 01432, United States
Unknown Facility
Lincoln, Nebraska, 68506, United States
Unknown Facility
Ridgewood, New Jersey, 07450, United States
Unknown Facility
Albany, New York, 12205, United States
Unknown Facility
Stony Brook, New York, 11794, United States
Unknown Facility
Winston-Salem, North Carolina, 27157, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Dayton, Ohio, 45414, United States
Unknown Facility
Fairfield, Ohio, 45014, United States
Unknown Facility
Sandusky, Ohio, 44870, United States
Unknown Facility
Oklahoma City, Oklahoma, 73112, United States
Unknown Facility
Charleston, South Carolina, 29401, United States
Unknown Facility
Germantown, Tennessee, 38138, United States
Unknown Facility
Lackland Airforce Base, Texas, United States
Unknown Facility
Milwaukee, Wisconsin, 53215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bertram Pitt, MD
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 17, 2008
First Posted
April 21, 2008
Study Start
March 1, 2008
Primary Completion
October 1, 2009
Study Completion
December 1, 2009
Last Updated
January 30, 2009
Record last verified: 2009-01