Heart FailurePhase 3COLT-HFNCT05873881
COLchicine and Thiamine in Heart Failure Due to Ischemic Heart Disease
A Phase 3 study testing Colchicine 0.5 MG and Thiamine Mononitrate 300 mg in people with Heart Failure, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Colchicine 0.5 MG and Thiamine Mononitrate 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,500 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jan 2024to Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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 -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Hamilton Health Sciences Corporation
Hamilton, Ontario, L8L 2X2
Katie Porter, 905-521-2100 ext. 74559, porterk@hhsc.ca
Phil G. Joseph, MD
About this study
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
Read more
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
- Being tested
- Colchicine 0.5 MG, Colchicine placebo, Thiamine Mononitrate 300 mg
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 MGDrug
Oral colchicine 0.5 mg daily
Colchicine placeboDrug
Placebo colchicine daily
Thiamine Mononitrate 300 mgDrug
Thiamine Mononitrate 300 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Colchicine versus placebo | Placebo comparator | Randomization to colchicine or placebo Receives: Drug: Colchicine 0.5 MG; Drug: Colchicine placebo |
| Thiamine versus no thiamine | Experimental | Randomization to thiamine or to no thiamine in a PROBE design Receives: Drug: Thiamine Mononitrate 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colchicine arm: Time to first occurrence of a CV death, a HF event, MI, stroke, or arterial revascularization
Measured: 3.5 years
Thiamine arm: Time to first occurrence of a CV death, or a HF event
Measured: 3.5 years
Secondary outcomes (2)
Time to death
Measured: 3.5 years
Time to first hospitalization
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start29 Jan 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Factorial 1: Colchicine 0.5 mg daily or placebo Factorial 2: Thiamine 300mg daily or no thiamine
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Population Health Research Institute, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Philip G Joseph, M.D., Principal investigator, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873881
- Sponsor's protocol ID
- PHRI.COLT-HF
- Acronym
- COLT-HF
- Status last verified
- Sep 2026
- First submitted
- 15 May 2023
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COLchicine and Thiamine in Heart Failure Due to Ischemic Heart Disease
- ClinicalTrials.gov ID
- NCT05873881
- Acronym / sponsor ID
- COLT-HF / PHRI.COLT-HF
- Conditions
- Heart Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Population Health Research Institute, Canadian Institutes of Health Research (CIHR)
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Factorial 1: Colchicine 0.5 mg daily or placebo Factorial 2: Thiamine 300mg daily or no thiamine
| Arm | Type | Receives |
|---|---|---|
| Colchicine versus placebo | Placebo comparator | Drug: Colchicine 0.5 MG, Drug: Colchicine placeboRandomization to colchicine or placebo |
| Thiamine versus no thiamine | Experimental | Drug: Thiamine Mononitrate 300 mgRandomization to thiamine or to no thiamine in a PROBE design |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >/= 45 years
- Documented ischemic HF as the etiology of HF, which includes:
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine 0.5 MGOral colchicine 0.5 mg daily | Drug | Colchicine versus placebo |
| Colchicine placeboPlacebo colchicine daily | Drug | Colchicine versus placebo |
| Thiamine Mononitrate 300 mgThiamine Mononitrate 300 mg daily | Drug | Thiamine versus no thiamine |
Primary outcome
Colchicine arm: Time to first occurrence of a CV death, a HF event, MI, stroke, or arterial revascularization
Time frame: 3.5 years
Thiamine arm: Time to first occurrence of a CV death, or a HF event
Time frame: 3.5 years
2 secondary outcomes
Time to death
Time frame: 3.5 years
Time to first hospitalization
Time frame: 3.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philip G Joseph, M.D. principal investigator
Population Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colchicine 0.5 MG and Thiamine Mononitrate 300 mg in people with Heart Failure, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philip G Joseph, M.D. (905-521-2100 ext. 40743, philip.joseph@phri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colchicine arm: Time to first occurrence of a CV death, a HF event, MI, stroke, or arterial revascularization (time frame: 3.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.