COLchicine and Thiamine in Heart Failure Due to Ischemic Heart Disease
ConditionHeart Failure
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age45+
SponsorHamilton Health Sciences Corporation
About this trial
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 criteria
Qualifiers
Age >/= 45 years
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
Disqualifiers
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.**
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
Trial design
Treatments tested in this trial
- Colchicine 0.5 MG
- Colchicine placebo
- Thiamine Mononitrate 300 mg
Treatment groups
2,500 Participants
are divided into 2 treatment groupsSponsors and collaborators
Hamilton Health Sciences Corporation
Lead sponsor
Population Health Research Institute
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov