RecruitingPhase 2Phase 3NCT05253794

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

Sponsor

Ottawa Heart Institute Research Corporation

Enrollment

24 participants

Start Date

Jul 1, 2022

Study Type

INTERVENTIONAL

Conditions

Inflammation Aortic Stenosis

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

Min Age: 18 Years

Inclusion Criteria3

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 Criteria18

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