COLchicine and Thiamine in Heart Failure Due to Ischemic Heart Disease

Prior treatment

• Use of a ventricular assist device or prior heart transplant
• Coronary revascularization (coronary artery bypass graft surgery or percutaneous coronary intervention) within the 4 weeks prior to enrollment, or planned within the next 4 weeks.
• Concurrent use of other experimental pharmacologic agents -

Other illness

• History of allergic reaction to colchicine or to thiamine; or current or planned use of cyclosporine, verapamil, diltiazem, azole antifungal, macrolide antibiotic (except azithromycin), or HIV protease inhibitor
• Severe valvular disease
• History of liver cirrhosis

Lab values

• Chronic and severe renal dysfunction defined as eGFR \< 15 mL/min/1.73m2 based on local laboratory measurement done within 6 months prior to run-in\*\*\*

Age

• Active malignancy (excluding basal cell or treated squamous cell carcinoma of the skin) requiring treatment and with a life-expectancy of \< 2 years.

Other

• Female who is pregnant, breast-feeding, or of childbearing potential and not using an effective form of birth control\*
• Regular or required use colchicine or thiamine for other clinical indications.\*\*

• Age \>/= 45 years
• Documented ischemic HF as the etiology of HF, which includes:
  • a prior history of CAD (defined as a history of myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, or non-invasive or invasive cardiac testing consistent with a diagnosis of CAD), and
  • determination of CAD to be the cause primary cause of HF based on local investigator assessment
• New York Heart Association (NYHA) class II-IV symptoms
• Documented LVEF \</= 45% within 1 year prior to enrollment
• Optimization of HF treatment based on local practice.
• Ambulatory HF patients or stable hospitalized patients with HF will both be eligible for enrollment in the trial. For hospitalized patients, enrollment will require i) evidence of clinical stability from HF defined as no use of an inotropic agent or intravenous diuretic agent in the prior 24, and ii) expected discharge from hospital in the next 72 hours.