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Colchicine + 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 up to 5 years
Awards & highlights
Pivotal 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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

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Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor
377 Previous Clinical Trials
337,900 Total Patients Enrolled
10 Trials studying Heart Failure
31,807 Patients Enrolled for Heart Failure
Population Health Research InstituteOTHER
164 Previous Clinical Trials
716,014 Total Patients Enrolled
9 Trials studying Heart Failure
31,049 Patients Enrolled for Heart Failure
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,388 Previous Clinical Trials
26,515,573 Total Patients Enrolled
31 Trials studying Heart Failure
2,875,741 Patients Enrolled for Heart Failure
~1667 spots leftby Jun 2027
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