COLchicine and Thiamine in Heart Failure Due to Ischemic Heart Disease

NCT05873881 | Recruiting Phase 3 DMC

• 1 other identifier: PHRI.COLT-HF
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Colchicine arm: Time to first occurrence of a CV death, a HF event, MI, stroke, or arterial revascularization

  3.5 years

• Thiamine arm: Time to first occurrence of a CV death, or a HF event

  3.5 years

Secondary Outcomes (2)

• Time to death

  3.5 years

• Time to first hospitalization

  3.5 years

Study Arms (2)

Colchicine versus placebo

PLACEBO COMPARATOR

Randomization to colchicine or placebo

Drug: Colchicine 0.5 MG; Drug: Colchicine placebo

Thiamine versus no thiamine

EXPERIMENTAL

Randomization to thiamine or to no thiamine in a PROBE design

Drug: Thiamine Mononitrate 300 mg

Interventions

Colchicine 0.5 MG DRUG

Oral colchicine 0.5 mg daily

Colchicine versus placebo

Colchicine placebo DRUG

Placebo colchicine daily

Colchicine versus placebo

Thiamine Mononitrate 300 mg DRUG

Thiamine Mononitrate 300 mg daily

Thiamine versus no thiamine

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 non-invasive or invasive cardiac testing consistent with a diagnosis of CAD), and
• 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 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.

You may not qualify 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, 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 -

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Population Health Research Institute: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Hamilton Health Sciences Corporation

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Colchicine; Thiamine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Pyrimidines

Study Officials

• Philip G Joseph, M.D.

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip G Joseph, M.D.

CONTACT

905-521-2100; philip.joseph@phri.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Factorial 1: Placebo controlled. Factorial 2: Prospective Randomized Open Blinded End-point (PROBE) design
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Factorial 1: Colchicine 0.5 mg daily or placebo Factorial 2: Thiamine 300mg daily or no thiamine

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 24, 2023
• Study Start: January 29, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)