Actively Recruiting

Phase 3
Age: 45Years +
All Genders
NCT05873881

COLchicine and Thiamine in Heart Failure Due to Ischemic Heart Disease

Led by Hamilton Health Sciences Corporation · Updated on 2025-06-19

2500

Participants Needed

1

Research Sites

174 weeks

Total Duration

On this page

Sponsors

H

Hamilton Health Sciences Corporation

Lead Sponsor

P

Population Health Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

COLchicine and Thiamine in Heart Failure Due to Ischemic Heart Disease

Who Can Participate

Age: 45Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 45 years or older
  • Documented ischemic heart failure, including prior coronary artery disease or heart procedures
  • New York Heart Association (NYHA) class II-IV heart failure symptoms
  • Left ventricular ejection fraction (LVEF) of 45% or less within 1 year prior to enrollment
  • Optimized heart failure treatment according to local practice
  • Ambulatory or stable hospitalized heart failure patients with no recent inotropic or intravenous diuretic use and expected hospital discharge within 72 hours
Not Eligible

You will not qualify if you...

  • Female participants who are pregnant, breastfeeding, or of childbearing potential without effective birth control
  • Regular or required use of colchicine or thiamine for other reasons
  • Allergic reactions to colchicine or thiamine; or use of certain interacting medications including cyclosporine, verapamil, diltiazem, azole antifungals, most macrolide antibiotics, or HIV protease inhibitors
  • Use of ventricular assist device or prior heart transplant
  • Coronary revascularization within 4 weeks before or planned within 4 weeks after enrollment
  • Severe valvular heart disease
  • Severe chronic kidney disease with eGFR less than 15 mL/min/1.73m2 measured within 6 months prior to run-in
  • History of liver cirrhosis
  • Active cancer requiring treatment with life expectancy under 2 years (excluding certain skin cancers)
  • Concurrent use of other experimental drug treatments

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hamilton Health Sciences Corporation

Hamilton, Ontario, Canada, L8L 2X2

Actively Recruiting

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Research Team

P

Philip G Joseph, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

2

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