BridgeMD
COLchicine and Thiamine in Heart Failure due to Ischemic Heart Disease (COLT-HF)
EU CTIS ID: 2023-506675-96-00
What this study is testing
In an RCT of individuals with HF secondary to ischemic heart disease (IHD): 1) To examine the impact of colchicine compared to placebo on the composite outcome of CV death, a HF event (defined a HF hospitalization or urgent HF visit), or ischemic cardiovascular events (myocardial infarction, ischemic stroke, or arterial revascularization). 2) To examine the impact of thiamine on the composite outcome of CV death, or HF hospitalization.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age greater than or equal to 45 years
- Documented ischemic heart disease as the etiology of HF, which includes: a) a history of CAD, and b) determination of the cause of HF to be due to IHD based on local investigator assessment
- NYHA class II-IV symptoms
- Documented LVEF less than or equal to 45% within 1 year prior to enrollment
- Optimal medical treatment for HF as per local clinical practice
- Participants can be enrolled in the ambulatory or hospitalized setting
You likely can't join if
- Female who is pregnant, breast-feeding or is considering becoming pregnant during the study
- Concurrent use of other experimental pharmacologic agents
- 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
- Severe valvular disease
See the full eligibility criteria
- Age greater than or equal to 45 years
- Documented ischemic heart disease as the etiology of HF, which includes: a) a history of CAD, and b) determination of the cause of HF to be due to IHD based on local investigator assessment
- NYHA class II-IV symptoms
- Documented LVEF less than or equal to 45% within 1 year prior to enrollment
- Optimal medical treatment for HF as per local clinical practice
- Participants can be enrolled in the ambulatory or hospitalized setting
- Female who is pregnant, breast-feeding or is considering becoming pregnant during the study
- Concurrent use of other experimental pharmacologic agents
- 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
- Severe valvular disease
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- India
- Brazil
- Colombia
- Argentina
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; India; Brazil; Colombia; Argentina. 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 EU CTIS; the study team decides eligibility.