RecruitingPhase 3NCT05873881

COLchicine and Thiamine in Heart Failure Due to Ischemic Heart Disease

Sponsor

Hamilton Health Sciences Corporation

Enrollment

2,500 participants

Start Date

Jan 29, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure

Summary

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

Eligibility

Min Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether colchicine and thiamine (vitamin B1) together can improve outcomes in people with heart failure caused by coronary artery disease. You may be eligible if... - You are 45 or older - Your heart failure is confirmed to be caused by coronary artery disease (e.g., prior heart attack, bypass surgery, or stenting) - You have NYHA heart failure symptoms (class II–IV) - Your heart ejection fraction (LVEF) is 45% or less within the last year - You are an outpatient or a stable hospitalized patient expected to go home within 72 hours You may NOT be eligible if... - You are pregnant, breastfeeding, or of childbearing potential without using contraception - You regularly take colchicine or thiamine for other conditions - You are allergic to colchicine or thiamine, or take certain interacting medications (e.g., cyclosporine, verapamil, certain antifungals or antibiotics) - You use a ventricular assist device or have had a heart transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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