Health Condition 1: - Health Condition 2: I509- Heart failure, unspecified
Conditions
Interventions
Intervention1: Colchicine: 0.5 mg once daily Thiamine: 200 mg( 2 tablets of 100mg each) once daily: Participants will be randomized to receive colchicine or placebo AND to receive thiamine or no thiam
Sponsors
Population Health Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: We will use the following inclusion criteria to identify eligible HF patients: 1. Age > 45years 2. Documented ischemic HF as the etiology of HF, which includes: a) 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 b) determination of CAD to be the cause primary cause of HF based on local investigator assessment 3. New York Heart Association (NYHA) class II-IV symptoms 4. Documented LVEF < 45% within 1 year prior to enrollment 5. Optimization of HF treatment based on local practice. 6. 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.
Exclusion criteria
Exclusion criteria: Female who is pregnant, breastfeeding or of childbearing potential and not using an effective form of birth control Regular or required use colchicine or thiamine for other clinical indications 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.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.Severe valvular disease Chronic and severe renal dysfunction defined as eGFR15 mLmin1.73m2 based on local laboratory measurement done within 6 months prior to run-in History of liver cirrhosis Active malignancy excluding basal cell or treated squamous cell carcinoma of the skin requiring treatment and with a life-expectancy of less than 2 years. Concurrent use of other experimental pharmacologic agents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Colchicine vs. placebo: Time to first occurrence of a CV death, a HF event, MI, stroke or arterial revascularization Thiamine vs. control: Time to first occurrence of a CV death or a HF eventTimepoint: Baseline, Randomization, 6 months, and then at 6-month intervals until study end(4years) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to death from any cause, and 2) time to first hospitalization from any causeTimepoint: Time to death from any cause, and 2) time to first hospitalization from any cause | — |
Countries
Argentina, Canada, Colombia, Ecuador, Germany, India, Poland
Contacts
Public ContactDr Deepa S
St Johns Research Institute
Outcome results
None listed