Beginning a Randomized Evaluation of the AGE Breaker Alagebrium in Diastolic Heart Failure (BREAK-DHF-I)
- Registration Number
- NCT00662116
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 160
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 placebo - 1 alagebrium -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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