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Anti-inflammatory drug

Colchicine 0.5 mg die for Heart Failure (COLpEF Trial)

Phase 2

Waitlist Available

Led By Nadia Bouabdallaoui, MD

Research Sponsored by Montreal Heart Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

NYHA functional class II to IV;

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 6 months in hs-crp

Awards & highlights

COLpEF Trial Summary

This trial will help determine if colchicine is an effective treatment for HFpEF by reducing inflammation.

Eligible Conditions

Heart Failure
Inflammation
Colchicine

COLpEF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

You have moderate to severe heart failure, as determined by your doctor.

COLpEF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 6 months in hs-crp

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 6 months in hs-crp

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 6 months in hs-crp for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in hs-CRP (C reactive protein)

Secondary outcome measures

Change in circulating biomarkers of hemodynamic stress

Change in circulating biomarkers of myocardial injury

Change in functional status and symptoms

+1 more

Other outcome measures

Safety endpoints

COLpEF Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Colchicine 0.5 mg dieActive Control1 Intervention

Colchicine 0.5 mg die

Group II: Colchicine 0.5 mg bidActive Control1 Intervention

Colchicine 0.5 mg bid

Group III: PlaceboPlacebo Group1 Intervention

Placebo

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Montreal Heart InstituteLead Sponsor

120 Previous Clinical Trials

68,805 Total Patients Enrolled

24 Trials studying Heart Failure

10,665 Patients Enrolled for Heart Failure

Nadia Bouabdallaoui, MDPrincipal InvestigatorMontreal Heart Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is Colchicine 0.5 mg bid effective in treating?

"Typically, colchicine is given at a dosage of 0.5mg twice a day to patients suffering from gout flares. However, it can also be used to ameliorate the symptoms of Behcet's syndrome, postcommissurotomy syndrome, and familial mediterranean fever."

Answered by AI

Is Colchicine 0.5 mg bid considered to be a safe medication?

"Colchicine 0.5 mg bid is currently in Phase 2 of clinical trials. While there is some evidence supporting its safety, more research is needed to confirm its efficacy."

Answered by AI

Would someone who is over the age of 70 still be able to participate in this research project?

"This particular medical trial is only enrolling patients that are between 40 to 80 years old. In contrast, there are 54 clinical trials for patients under 18 and 1026 for those over 65."

Answered by AI

Is Colchicine 0.5 mg bid a new medication being trialed?

"As of now, there are a total of 32 clinical trials ongoing for Colchicine 0.5 mg bid. Out of these, 13 are in Phase 3. The vast majority of these trials are based in New york City, New York, however, there are a total of 189 locations running these trials."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Outcome of Heart Failure with Preserved Ejection Fraction in a Population-based Study

Bhatia, R. Sacha, Jack V. Tu, Douglas S. Lee, Peter C. Austin, Jiming Fang, Annick Haouzi, Yanyan Gong, and Peter P. Liu. 2006. “Outcome of Heart Failure with Preserved Ejection Fraction in a Population-based Study”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa051530.

CirculationJournal

Heart Disease and Stroke Statistics—2018 Update: A Report from the American Heart Association

Benjamin, Emelia J., Salim S. Virani, Clifton W. Callaway, Alanna M. Chamberlain, Alexander R. Chang, Susan Cheng, Stephanie E. Chiuve, et al.. 2018. “Heart Disease and Stroke Statistics—2018 Update: A Report from the American Heart Association”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/cir.0000000000000558.

Seminars in Arthritis and RheumatismJournal

Colchicine—update on Mechanisms of Action and Therapeutic Uses

Leung, Ying Ying, Laura Li Yao Hui, and Virginia B. Kraus. 2015. “Colchicine—update on Mechanisms of Action and Therapeutic Uses”. Seminars in Arthritis and Rheumatism. Elsevier BV. doi:10.1016/j.semarthrit.2015.06.013.

Journal of the American College of CardiologyJournal