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Anti-inflammatory

COLCHICINE for Coronary Artery Disease (COL-Micro-HF Trial)

Phase 2 & 3

Waitlist Available

Research Sponsored by Montreal Heart Institute

Eligibility Criteria Checklist

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

Must have

Chronic symptomatic HF and left ventricular ejection fraction (LVEF) > 40% within 12 months prior to the screening visit documented by one of the following: HF requiring hospitalization and IV diuretics within 12 months of study entry, or NTproBNP > or = 150pg/ml in sinus rhythm or NTproBNP > or = 450pg/ml in chronic atrial fibrillation

New York Heart Association Class, NYHA functional class II to (ambulatory) IV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 6 months

Awards & highlights

COL-Micro-HF Trial Summary

This trial will investigate how colchicine affects coronary flow reserve, which is a measure of how well the small blood vessels in the heart are working. The study will compare colchicine to a placebo

Who is the study for?

This trial is for patients with heart failure who still have a decent amount of blood leaving the heart each time it pumps (ejection fraction over 40%). It's also for those whose ejection fraction has gotten better over time. People can't join if they're already on certain medications or have health conditions that could interfere with the study.Check my eligibility

What is being tested?

The trial is testing whether Colchicine, at a dose of 0.5 milligrams, can improve how well small blood vessels in the heart work compared to a placebo. The main thing being measured is the coronary flow reserve which tells us about these tiny vessels' health.See study design

What are the potential side effects?

Colchicine may cause side effects like diarrhea, nausea, and possible muscle pain or weakness. There might be other risks too, depending on an individual's overall health.

COL-Micro-HF Trial Eligibility Criteria

Inclusion Criteria

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

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I have heart failure with an LVEF over 40% and have been hospitalized or have high NTproBNP levels.

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My heart condition limits my physical activity but I can still walk.

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I am 40 years old or older.

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I understand and can agree to the study's procedures and risks.

COL-Micro-HF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 months 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 coronary flow reserve (CFR) between baseline and six months

COL-Micro-HF Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: COLCHICINEActive Control1 Intervention

Patients will be randomly assigned in a 1:1 ratio to receive colchicine 0.5 mg daily or a matched placebo.

Group II: PLACEBOPlacebo Group1 Intervention

Patients will be randomly assigned in a 1:1 ratio to receive colchicine 0.5 mg daily or a matched placebo.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Montreal Heart InstituteLead Sponsor

120 Previous Clinical Trials

68,759 Total Patients Enrolled

21 Trials studying Coronary Artery Disease

13,923 Patients Enrolled for Coronary Artery Disease

Frequently Asked Questions

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

Are new participants still being accepted for enrollment in this ongoing research study?

"As per clinicaltrials.gov, the current information indicates that this particular trial is not in the active recruitment phase. The initial posting of the trial on March 1st, 2024, was last edited on January 10th, 2024. However, it is worth noting that there are currently 1277 other studies actively seeking participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reversing Microvascular Dysfunction in Heart Failure With Preserved Ejection Fraction

2024. "Reversing Microvascular Dysfunction in Heart Failure With Preserved Ejection Fraction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06217120.