Effect of Colchicine on the Progression of Aortic Valve Stenosis - a Pilot Study
Who is this study for? Patients with aortic valve stenosis
What treatments are being studied? Colchicine
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
COPAS pilot is a pilot single center double blinded randomized study to determine the effect of targeted anti-inflammation therapy using colchicine, on valvular calcification activity using imaging, i.e. aortic valvular NaF uptake. The current proposal uses a randomized design to evaluate the effect of colchicine vs. placebo on valvular calcification activity over 6 months measured using NaF PET
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• mild to moderate aortic stenosis defined by a mean pressure gradient using transthoracic echocardiography (TTE) between 15-25mmHg.
• age greater than18 years;
• given informed consent.
Locations
Other Locations
Canada
University of Ottawa Heart Institute
RECRUITING
Ottawa
Contact Information
Primary
David Messika-Zeitoun
DMessika-zeitoun@ottawaheart.ca
613 796 7000
Backup
Kevin E Boczar
kboczar@ottawaheart.ca
613 796 7000
Time Frame
Start Date: 2022-07-01
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 24
Treatments
Experimental: Colchicine
Colchicine 0.6mg PO daily for 6 months
Placebo_comparator: Placebo
Placebo tablet daily for 6 months
Related Therapeutic Areas
Sponsors
Leads: Ottawa Heart Institute Research Corporation