COLchicine and Thiamine in Heart Failure due to Ischemic Heart Disease (COLT-HF)
Project Description
Description:
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.
Project Duration
2024 - Ongoing
Project Lead
Dr. Denis Xavier
Authors
PI- Dr Denis Xavier, Co-I- Dr Mangala Rao
Project Status
ongoing