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Thiamine versus no thiamine for Heart Failure (COLT-HF Trial)
Phase 3
Recruiting
Led By Philip G Joseph, M.D.
Research Sponsored by Hamilton Health Sciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3.5 years
Awards & highlights
COLT-HF Trial Summary
This trial aims to see if colchicine and thiamine can help improve heart failure in patients with ischemic heart disease. It wants to find out if colchicine can reduce the risk of
Who is the study for?
This trial is for adults over 45 with heart failure due to coronary artery disease. They must have a history of heart issues like a past heart attack or surgery, symptoms matching NYHA class II-IV, and reduced heart function (LVEF ≤ 45%) documented in the last year. Both outpatients and stable hospitalized patients can join if they meet certain stability criteria.Check my eligibility
What is being tested?
The study tests whether colchicine or thiamine reduces cardiovascular death or events in ischemic heart disease-related failure. Participants first try colchicine for tolerance, then are randomly assigned to get either colchicine or placebo, and thiamine or no supplement.See study design
What are the potential side effects?
Colchicine may cause gastrointestinal problems, blood disorders, muscle pain, and weakness. Thiamine is generally safe but could cause allergic reactions or irritation where injected if not taken orally.
COLT-HF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Colchicine arm: Time to first occurrence of a CV death, a HF event, MI, stroke, or arterial revascularization
Thiamine arm: Time to first occurrence of a CV death, or a HF event
Secondary outcome measures
Time to death
Time to first hospitalization
COLT-HF Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Thiamine versus no thiamineExperimental Treatment1 Intervention
Randomization to thiamine or to no thiamine in a PROBE design
Group II: Colchicine versus placeboPlacebo Group2 Interventions
Randomization to colchicine or placebo
Find a Location
Who is running the clinical trial?
Hamilton Health Sciences CorporationLead Sponsor
368 Previous Clinical Trials
298,501 Total Patients Enrolled
10 Trials studying Heart Failure
31,807 Patients Enrolled for Heart Failure
Population Health Research InstituteOTHER
155 Previous Clinical Trials
677,412 Total Patients Enrolled
9 Trials studying Heart Failure
31,049 Patients Enrolled for Heart Failure
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,345 Previous Clinical Trials
26,451,067 Total Patients Enrolled
29 Trials studying Heart Failure
2,875,181 Patients Enrolled for Heart Failure
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any available slots for new participants in this medical trial?
"As indicated on clinicaltrials.gov, patient recruitment is ongoing for this trial. The study was initially shared on January 29th, 2024, and the most recent update was made on February 12th of the same year."
Answered by AI
What are the comparative risks of Thiamine administration compared to its omission in patients?
"Power's assessment on the safety of thiamine compared to no thiamine in this Phase 3 trial is rated at 3, indicating that there exists preliminary efficacy data and recurrent safety evidence."
Answered by AI
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