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

NCT ID: NCT05253794

Last Updated: 2024-12-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2026-09-30

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.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

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 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.

Conditions

Aortic Stenosis; Inflammation

Keywords

colchicine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Colchicine

Colchicine 0.6mg PO daily for 6 months

Group Type: EXPERIMENTAL

Colchicine 0.6 mg

Intervention Type: DRUG

oral tablet daily for 6 months

Placebo

Placebo tablet daily for 6 months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral tablet daily for 6 months

Interventions

Colchicine 0.6 mg

oral tablet daily for 6 months

Intervention Type: DRUG

Placebo

oral tablet daily for 6 months

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Messika-Zetioun@ottawaheart.ca

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Locations

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

David Messika-Zeitoun

Role: CONTACT

Phone: 613 796 7000

Email: DMessika-zeitoun@ottawaheart.ca

Kevin E Boczar

Role: CONTACT

Phone: 613 796 7000

Email: kboczar@ottawaheart.ca

Facility Contacts

David Messika-Zeitoun

Role: primary

Other Identifiers

20210526

Identifier Type: -

Identifier Source: org_study_id