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| Name | Class |
|---|---|
| Population Health Research Institute | OTHER |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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:
Participants will undergo the following procedures:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine versus placebo | Placebo Comparator | Randomization to colchicine or placebo |
|
| Thiamine versus no thiamine | Experimental | Randomization to thiamine or to no thiamine in a PROBE design |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine 0.5 MG | Drug | Oral colchicine 0.5 mg daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to death | 3.5 years | |
| Time to first hospitalization | 3.5 years |
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Inclusion Criteria:
Age >/= 45 years
Documented ischemic HF as the etiology of HF, which includes:
New York Heart Association (NYHA) class II-IV symptoms
Documented LVEF \
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philip G Joseph, M.D. | Contact | 905-521-2100 | 40743 | philip.joseph@phri.ca |
| Name | Affiliation | Role |
|---|---|---|
| Philip G Joseph, M.D. | Population Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Health Sciences Corporation | Recruiting | Hamilton | Ontario | L8L 2X2 | Canada |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| D013831 | Thiamine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
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Factorial 1: Colchicine 0.5 mg daily or placebo Factorial 2: Thiamine 300mg daily or no thiamine
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Factorial 1: Placebo controlled. Factorial 2: Prospective Randomized Open Blinded End-point (PROBE) design
| Colchicine placebo |
| Drug |
Placebo colchicine daily |
|
| Thiamine Mononitrate 300 mg | Drug | Thiamine Mononitrate 300 mg daily |
|
| D009930 |
| Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011743 | Pyrimidines |