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NCT Number: NCT05873881

COLchicine and Thiamine in Heart Failure Due to Ischemic Heart Disease

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

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hamilton Health Sciences Corporation

Hamilton, Ontario, L8L 2X2, Canada

Location status: Recruiting

Location contact

Eva Lonn, MD

SUB_INVESTIGATOR

Katie Porter

CONTACT

[email protected]

905-521-2100 ext. 74559

Phil G. Joseph, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 -

Treatment and study plan

Colchicine 0.5 MG

Drug

Oral colchicine 0.5 mg daily

Colchicine placebo

Drug

Placebo colchicine daily

Thiamine Mononitrate 300 mg

Drug

Thiamine Mononitrate 300 mg daily

Primary outcomes

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

    Time frame: 3.5 years

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

    Time frame: 3.5 years

Secondary outcomes

  1. Time to death

    Time frame: 3.5 years

  2. Time to first hospitalization

    Time frame: 3.5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Philip G Joseph, M.D.

CONTACT

[email protected]

905-521-2100 ext. 40743

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Population Health Research Institute

Registry information

Acronym: COLT-HF

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 24, 2023
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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