Status:
TERMINATED
Beginning a Randomized Evaluation of the AGE Breaker Alagebrium in Diastolic Heart Failure (BREAK-DHF-I)
Lead Sponsor:
Synvista Therapeutics, Inc
Conditions:
Diastolic Heart Failure
Eligibility:
All Genders
50+ years
Phase:
PHASE2
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 exerci...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00662116
Start Date
March 1 2008
End Date
December 1 2009
Last Update
January 30 2009
Active Locations (30)
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1
Birmingham, Alabama, United States, 35294
2
Huntsville, Alabama, United States, 35801
3
Mobile, Alabama, United States, 36608
4
Anaheim, California, United States