NCT05253794

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Ottawa Heart Institute Research Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Colchicine 0.6 mg	oral tablet daily for 6 months
DRUG	Placebo	oral tablet daily for 6 months

Timeline

• Start date: 2022-07-01
• Primary completion: 2025-08-01
• Completion: 2026-09-30
• First posted: 2022-02-24
• Last updated: 2024-12-11

Locations

1 site across 1 country: Canada