Clinical Trial: Beginning a Randomized Evaluation of the AGE Breaker Alagebrium in Diastolic Heart Failure (BREAK-DHF-I)
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Effects of Alagebrium on Exercise in Subjects With Diastolic Heart Failure
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 Summary:
Sponsor: Synvista Therapeutics, Inc
Current Primary Outcome: The primary efficacy measure will be exercise tolerance as assessed utilizing the 6 Minute Walk Test [ Time Frame: Assessed at baseline, week 12 and week 24 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- QOL as assessed by the Kansas City Cardiomyopathy Questionnaire [ Time Frame: baseline, week 12 and week 24 ]
- To assess New York Heart Association Classification [ Time Frame: Baseline, week 12 and week 24 ]
- To evaluate cardiovascular death or hospitalization for heart failure [ Time Frame: Will be assessed during the entire 24 wk trial ]
Original Secondary Outcome: Same as current
Information By: Synvista Therapeutics, Inc
Dates:
Date Received: April 17, 2008
Date Started: March 2008
Date Completion: December 2009
Last Updated: January 29, 2009
Last Verified: January 2009
