RecruitingPhase 2NCT06081049

The COLchicine HEART Failure PRESERVED Trial (COLHEART-PRESERVED)


Sponsor

Tor Biering-Sørensen

Enrollment

152 participants

Start Date

Jan 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to investigate the effects of colchicine on heart failure related health status, quality of life, and vascular and cardiac function in patients with heart failure with preserved ejection fraction (HFpEF).


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether colchicine — a common anti-inflammatory medication used for gout — can help people with heart failure with preserved ejection fraction (a type of heart failure where the heart pumps normally but is too stiff). Researchers believe reducing inflammation may ease symptoms. **You may be eligible if...** - You have been diagnosed with heart failure with a preserved pumping function (ejection fraction of 45% or more) - You have had heart failure symptoms for at least 30 days and currently have symptoms (shortness of breath, fatigue) - Your echocardiogram shows structural heart changes consistent with this type of heart failure - Your BNP blood test level is elevated - Your BMI is under 40 **You may NOT be eligible if...** - You are already taking colchicine for gout or another reason - You are allergic to colchicine - You have very high blood pressure, severe liver disease, or kidney disease (low kidney function) - You have a history of cancer (except some skin cancers) - You have recently been hospitalized for heart failure, heart attack, or major cardiac surgery - You are pregnant, breastfeeding, or planning pregnancy - You have inflammatory bowel disease or chronic diarrhea Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGColchicine

0.5 mg once daily

DRUGPlacebo

Once daily


Locations(1)

Center for Translational Cardiology and Pragmatic Randomized Trials, Herlev and Gentofte Hospital

Hellerup, Denmark

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NCT06081049


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