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New treatment option for Heart Failure
Official title COLchicine and Thiamine in Heart Failure Due to Ischemic Heart Disease
ClinicalTrials.gov ID: NCT05873881
What this study is testing
What is Colchicine 0.5 MG?
Colchicine 0.5 MG is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for heart failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- 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...
- Severe valvular disease
See the full eligibility criteria
- 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...
- 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...
- 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
- 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 eGFR \< 15 mL/min/1.73m2 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 \< 2 years.
- Concurrent use of other experimental pharmacologic agents -
The study team makes the final eligibility decision.
Where it's taking place
- Hamilton, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamilton, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.