COLchicine and Thiamine in Heart Failure due to Ischemic Heart Disease (COLT-HF)


a) Background: COLT-HF will be a 2x2 factorial RCT in participants with heart failure secondary to IHD. The trial will test the independent effects of i) colchicine versus placebo, and ii) thiamine versus no thiamine (i.e. control) in a prospective, randomized, open-label, blinded-endpoint (PROBE) design. This will be an event driven trial with a planned accrual of at least 700 primary outcome events for the main comparison of colchicine versus placebo. The sample size for the trial is 2500 participants, and mean follow up is expected to be 3.5 years.

b) Aim/objective: In an RCT of individuals with HF secondary to ischemic heart disease (IHD):

1) To examine the impact of colchicine compared to placebo on the composite outcome of CV death, a HF event (defined a HF hospitalization or urgent HF visit), or ischemic cardiovascular events (myocardial infarction, ischemic stroke, or arterial revascularization).

2) To examine the impact of thiamine on the composite outcome of CV death, or HF hospitalization

c) Methods: Colchicine: 0.5 mg once daily, or placebo* Thiamine: 200 mg once daily, or no thiamine (control) *every other day dosing will be used for patients with an eGFR between 15-29 mL/min/1.73m2

e) Sample size: Global - 2500 patients; India – 500 patients

f) Study update: Total number of participating sites – 13. Received HMSC and EC approval (from all centres). The site initiation will start by early 2024

g) Updated as on: 01st January 2024

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