CompletedPhase 2/3

Effect of Colchicine on the Progression of Aortic Valve Stenosis - A Pilot Study

Canada24 participantsStarted 2022-07-01

Plain-language 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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. bicuspid aortic valve
✕. associated moderate to severe aortic regurgitation
✕. associated other valvular pathology of moderate or greater severity
✕. LV dysfunction (EF\<50%);
✕. decompensated heart failure;
✕. active infection (e.g. pneumonia, active skin infections, and on antibiotics);
✕. chronic diarrhea;
✕. immune compromise (e.g. recurrent infection);

What they're measuring

Change in aortic valve calcification activity

Timeframe: 6 months

Trial details

NCT IDNCT05253794

SponsorOttawa Heart Institute Research Corporation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-31

View on ClinicalTrials.gov More Aortic Stenosis trials