Phase
Condition
Heart Defect
Inflammation
Congestive Heart Failure
Treatment
Colchicine 0.6 mg
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
mild to moderate aortic stenosis defined by a mean pressure gradient usingtransthoracic echocardiography (TTE) between 15-25mmHg.
age greater than18 years;
given informed consent.
Exclusion
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);
history of cancer within the last 3 years (other than a successfully treatedcutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ ofthe cervix).
active inflammatory conditions (e.g. rheumatoid arthritis, chronic inflammatorybowel 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 (thisincludes at least one form of highly effective and one effective method ofcontraception) throughout the study OR men capable of fathering a child who refuseto use contraception.
glomerular filtration rate (GFR) <50 ml/min/1.72m2;
Use of p-glycoprotein inhibitor (e.g. cyclosporine, verapamil, or quinidine) or astrong 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 hepaticdisease or with alanine aminotransferase (ALT) levels greater than 3 times the upperlimit of normal.
unable to give informed consent
Study Design
Study Description
Connect with a study center
University of Ottawa Heart Institute
Ottawa, Ontario K1Y 4W7
CanadaActive - Recruiting
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