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

• Status: Terminated
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Synvista Therapeutics, Inc

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