RecruitingPhase 1Phase 2NCT05637398

Colchicine in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction


Sponsor

I.M. Sechenov First Moscow State Medical University

Enrollment

40 participants

Start Date

Dec 15, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Heart failure with preserved left ventricular ejection fraction (HFpEF) is a syndrome associated with high morbidity and mortality rates. Systemic low-grade inflammation is acknowledged to be a fundamental pathophysiological mechanism of HFpEF. Interventions targeting inflammatory pathway is understudied in HFpEF. Colchicine is a safe and well tolerated anti-inflammatory drug, which interferes with several steps in the inflammatory process. The drug has been extensively studied in different cardiovascular pathologies except HFpEF. We assume that colchicine decreases inflammation and reduces sST2 levels in HFpEF.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether colchicine — a drug usually used for gout — can reduce inflammation and improve outcomes in patients with heart failure with preserved ejection fraction (HFpEF). This type of heart failure occurs when the heart pumps normally but the muscle has become stiff. **You may be eligible if...** - You are 40 years or older (male or female) - Your heart pumps normally (ejection fraction ≥50%) but you have symptoms of heart failure - Your blood has elevated levels of a heart stress marker (NT-proBNP) - You have evidence of abnormal heart structure on echocardiogram **You may NOT be eligible if...** - Your heart failure is due to a reduced pumping function (ejection fraction below 50%) - You do not have elevated NT-proBNP levels - You have conditions that make colchicine unsafe 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

The active treatment intervention consists of colchicine 0.5 mg twice daily that will be administrated by the investigator


Locations(2)

A Shchendrygina

Moscow, Russia

Anastasia Shchendrygina

Moscow, Russia

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NCT05637398


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