Hamilton Health Sciences Corporation
Hamilton, Ontario, L8L 2X2, Canada
Location status: Recruiting
Location contact
Eva Lonn, MD
SUB_INVESTIGATOR
Katie Porter
CONTACT
905-521-2100 ext. 74559
Phil G. Joseph, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05873881
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
Interested in participating?
Request Info45 year and older
All sexes
Interventional
Phase 3
Hamilton, Ontario, L8L 2X2, Canada
Location status: Recruiting
Eva Lonn, MD
SUB_INVESTIGATOR
Katie Porter
CONTACT
905-521-2100 ext. 74559
Phil G. Joseph, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral colchicine 0.5 mg daily
Placebo colchicine daily
Thiamine Mononitrate 300 mg daily
Time frame: 3.5 years
Time frame: 3.5 years
Time frame: 3.5 years
Time frame: 3.5 years
Contact information is provided by the study sponsor or research team.
Hamilton Health Sciences Corporation
Other
Acronym: COLT-HF
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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