Can a gout drug slow a stiff heart valve?
NCT ID NCT05253794
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tested whether colchicine, an anti-inflammatory drug, can slow the buildup of calcium in the aortic valve. 24 adults with mild-to-moderate aortic stenosis were randomly assigned to take colchicine or a placebo for 6 months. The study measured changes in valve calcification using a special PET scan.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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24 people
The number who actually took part.
- Started
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Jul 2022
- Finished
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Jan 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. mild to moderate aortic stenosis defined by a mean pressure gradient using transthoracic echocardiography (TTE) between 15-25mmHg. 2. age greater than18 years; 3. given informed consent. Exclusion Criteria: 1. bicuspid aortic valve 2. associated moderate to severe aortic regurgitation 3. associated other valvular pathology of moderate or greater severity 4. LV dysfunction (EF\<50%); 5. decompensated heart failure; 6. active infection (e.g. pneumonia, active skin infections, and on antibiotics); 7. chronic diarrhea; 8. immune compromise (e.g. recurrent infection); 9. 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). 10. active inflammatory conditions (e.g. rheumatoid arthritis, chronic inflammatory bowel disease, SLE, systemic anti-inflammatory therapy (e.g. prednisone, methotrexate)); 11. pregnancy (all women of child bearing potential will have a negative BHCG test; 12. breastfeeding; 13. 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. 14. glomerular filtration rate (GFR) \<50 ml/min/1.72m2; 15. Use of p-glycoprotein inhibitor (e.g. cyclosporine, verapamil, or quinidine) or a strong CYP3A4 inhibitor (e.g. ritonavir, clarithromycin, or ketoconazole); 16. Hemoglobin \< 105(women) \<110 (men) g/L; WBC \< 3.0x 10(9)/L, platelet count\< 110x 10(9)/L; 17. 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. 18. unable to give informed consent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
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