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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Diastolic Heart Failure

In brief

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.

Key facts

Study ID

NCT00662116

Run by

Synvista Therapeutics, Inc

People needed

160

Starts

2008-03-01

Expected to finish

2009-12-01

Last updated by the study team

2009-01-30

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Anaheim, California, United States
• Study site — Bakersfield, California, United States
• Study site — La Jolla, California, United States
• Study site — Roseville, California, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Covington, Georgia, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Louisville, Kentucky, United States
• Study site — Auburn, Maine, United States
• Study site — South Portland, Maine, United States
• Study site — Ayer, Massachusetts, United States
• Study site — Lincoln, Nebraska, United States
• Study site — Ridgewood, New Jersey, United States
• Study site — Albany, New York, United States
• Study site — Stony Brook, New York, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Dayton, Ohio, United States
• Study site — Fairfield, Ohio, United States
• Study site — Sandusky, Ohio, United States

Full record on ClinicalTrials.gov

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