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

Last updated: December 5, 2024
Sponsor: Ottawa Heart Institute Research Corporation
Overall Status: Active - Recruiting

Phase

2/3

Condition

Heart Defect

Inflammation

Congestive Heart Failure

Treatment

Colchicine 0.6 mg

Placebo

Clinical Study ID

NCT05253794
20210526
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. mild to moderate aortic stenosis defined by a mean pressure gradient usingtransthoracic echocardiography (TTE) between 15-25mmHg.

  2. age greater than18 years;

  3. given informed consent.

Exclusion

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 treatedcutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ ofthe cervix).

  10. active inflammatory conditions (e.g. rheumatoid arthritis, chronic inflammatorybowel 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 (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.

  14. glomerular filtration rate (GFR) <50 ml/min/1.72m2;

  15. Use of p-glycoprotein inhibitor (e.g. cyclosporine, verapamil, or quinidine) or astrong 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 hepaticdisease or with alanine aminotransferase (ALT) levels greater than 3 times the upperlimit of normal.

  18. unable to give informed consent

Study Design

Total Participants: 24
Treatment Group(s): 2
Primary Treatment: Colchicine 0.6 mg
Phase: 2/3
Study Start date:
July 01, 2022
Estimated Completion Date:
September 30, 2026

Study 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 NaF aortic valve uptake in patients with mild to moderate AS defined by a mean pressure gradient measured using transthoracic echocardiography (TTE) between 15-25 mm Hg after a 6-month period of treatment. The investigators plan to enroll 12 patients (6 males/6 females) in each arm (total sample size: 24 patients). Primary endpoint is the change in 18FNaF aortic valve uptake between baseline and 6 months in each arm. Parameters of interest are the maximal and total standard uptake values (SUVs) and tissue-to background ratios (TBRs) at the level of the aortic valve.

Connect with a study center

  • University of Ottawa Heart Institute

    Ottawa, Ontario K1Y 4W7
    Canada

    Active - Recruiting

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