Testing colchicine and thiamine for heart failure from ischemic heart disease

COLchicine and Thiamine in Heart Failure Due to Ischemic Heart Disease

This study is testing if colchicine and thiamine can help people with heart failure from ischemic heart disease feel better and reduce serious heart problems.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2500 (estimated)
• Ages: 45 Years and up
• Sex: All
• Sponsor: Hamilton Health Sciences Corporation (Academic / other)
• Locations: 1 site (Hamilton, Ontario)
• Trial ID: NCT05873881 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of colchicine and thiamine in patients with heart failure caused by ischemic heart disease. It employs a 2x2 factorial design where participants will first undergo a run-in phase to assess tolerance to colchicine before being randomized to receive either colchicine or a placebo, along with thiamine or no thiamine. The study will monitor clinical outcomes, side effects, and adherence to the treatment regimen over time. The primary focus is to determine if these interventions can reduce cardiovascular death and heart failure events.

Who should consider this trial

Good fit: Ideal candidates are adults aged 45 and older with documented ischemic heart failure and specific clinical criteria.

Not a fit: Patients with heart failure not related to ischemic heart disease or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new treatment options that significantly reduce the risk of cardiovascular events in patients with heart failure.

How similar studies have performed: While the specific combination of colchicine and thiamine in this context is novel, previous studies have shown promise in using colchicine for cardiovascular conditions.

Eligibility criteria

Inclusion Criteria:

1. Age \>/= 45 years
2. Documented ischemic HF as the etiology of HF, which includes:

   1. 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
   2. 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:

1. Female who is pregnant, breast-feeding, or of childbearing potential and not using an effective form of birth control\*
2. Regular or required use colchicine or thiamine for other clinical indications.\*\*
3. 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
4. Use of a ventricular assist device or prior heart transplant
5. 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.
6. Severe valvular disease
7. 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\*\*\*
8. History of liver cirrhosis
9. Active malignancy (excluding basal cell or treated squamous cell carcinoma of the skin) requiring treatment and with a life-expectancy of \< 2 years.
10. Concurrent use of other experimental pharmacologic agents -

Where this trial is running

Hamilton, Ontario

• Hamilton Health Sciences Corporation — Hamilton, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Philip G Joseph, M.D. — Population Health Research Institute
• Study coordinator: Philip G Joseph, M.D.

Conditions Heart Failure