Status:
RECRUITING
Effect of Colchicine on the Progression of Aortic Valve Stenosis - a Pilot Study
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Conditions:
Aortic Stenosis
Inflammation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
COPAS pilot is a pilot single center double blinded randomized study. The investigators will compare the effect of colchicine (0.6 mg daily - intervention arm) vs. placebo (control group) on the 18F N...
Eligibility Criteria
Inclusion
- 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
- 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);
- history of cancer within the last 3 years (other than a successfully treated cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix).
- active inflammatory conditions (e.g. rheumatoid arthritis, chronic inflammatory bowel disease, SLE, systemic anti-inflammatory therapy (e.g. prednisone, methotrexate));
- pregnancy (all women of child bearing potential will have a negative BHCG test;
- breastfeeding;
- Women of childbearing potential who refuse to use two forms of contraception (this includes at least one form of highly effective and one effective method of contraception) throughout the study OR men capable of fathering a child who refuse to use contraception.
- glomerular filtration rate (GFR) \<50 ml/min/1.72m2;
- Use of p-glycoprotein inhibitor (e.g. cyclosporine, verapamil, or quinidine) or a strong CYP3A4 inhibitor (e.g. ritonavir, clarithromycin, or ketoconazole);
- Hemoglobin \< 105(women) \<110 (men) g/L; WBC \< 3.0x 10(9)/L, platelet count\< 110x 10(9)/L;
- Patient with a history of cirrhosis, chronic active hepatitis or severe hepatic disease or with alanine aminotransferase (ALT) levels greater than 3 times the upper limit of normal.
- unable to give informed consent
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05253794
Start Date
July 1 2022
End Date
September 30 2026
Last Update
December 11 2024
Active Locations (1)
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1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7