Phase 3Recruiting
COLchicine and Thiamine in Heart Failure Due to Ischemic Heart Disease (COLT-HF)
- Sponsor
- Hamilton Health Sciences Corporation (Academic or other)
- Enrolment
- 2,500 planned
- Conditions
- Heart Failure
- Interventions
- Colchicine 0.5 MG; Colchicine placebo; Thiamine Mononitrate 300 mg
- Ages
- adults, older adults
- Registry
- NCT05873881
From the registry
The goal of this 2x2 factorial clinical trial is to test the efficacy of i) colchicine, and ii) thiamine in heart failure (HF) secondary to ischemic heart disease. The main questions it aims to answer are: * Does colchicine reduce the risk of cardiovascular (CV) death, a HF event, or an ischemic CV event * Does thiamine reduce the risk of cardiovascular (CV) death, or a HF event Participants will undergo the following procedures: * Run-in: All participants will receive colchicine 0.5 mg daily to assess drug tolerance over a 3-4 week period. * Randomization: If colchicine is tolerated during run-in, eligible participants will be randomized in a 2x2 factorial design to receive i) colchicine 0.5mg daily or placebo, and ii) thiamine 300mg daily or no thiamine. * Follow-up: Clinical outcomes, side effects, adverse events, and drug adherence will be captured during follow-up
Primary outcomes
- Colchicine arm: Time to first occurrence of a CV death, a HF event, MI, stroke, or arterial revascularization
- Thiamine arm: Time to first occurrence of a CV death, or a HF event