Heart Failure study: Colchicine vs Thiamine Mononitrate
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?
An investigational oral medicine being studied as a potential treatment for heart failure secondary to ischemic heart disease. It is designed to reduce inflammation by inhibiting microtubule formation in immune cells.
Also referred to as colchicine.
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 study wants to find out whether colchicine can lower the chance of death, a heart‑failure event, or a heart attack, and whether thiamine can lower the chance of death or a heart‑failure event.
- Who it's for
- It is looking for adults who have heart failure caused by blocked heart arteries and can tolerate a short test dose of colchicine.
- What's involved
- Participants first take colchicine for 3–4 weeks to see if they can tolerate it. Those who can are then randomly assigned to receive either colchicine or a placebo, and either thiamine or no thiamine, and are followed for outcomes and side effects.
- Time commitment
- The study lasts about 2–3 years, with regular clinic visits to monitor health, side effects, and medication use.
- 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
- 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
- Documented LVEF \</= 45% within 1 year prior to enrollment
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
- 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.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Hamilton, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.