CompletedPhase 1/2

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

Russia42 participantsStarted 2022-12-15

Plain-language 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.

Who can participate

Age range40 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 40 years of age, male and female * Left ventricular ejection fraction (LVEF) ≥ 50% * Symptoms and signs of heart failure * N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥300 pg/ml at baseline (patients in atrial fibrillation at baseline NT-proBNP ≥ 600 pg/ml), left atrial volume index (LAVI) \>34 mL/m2 or a left ventricular mass index (LVMI) =115 g/m2 for males and =95 g/m2 for females * body mass index (BMI) \> 30kg/m2 or diabetes mellitus Exclusion Criteria: * Hypertrophic cardiomyopathy, constrictive pericarditis, or cardiac amyloidosis * Acute decompensation of HF in the last 1 month * Valvular heart disease * Prior history of LVEF below 50% * Acute myocardial infarction in the last 3 months, cardiac surgery or cerebrovascular accident within the recent 6 months * Any active or chronic inflammatory diseases or infections * Patients with indication for colchicine therapy or history of colchicine intolerance * Severe hepatic (alanine aminotransferase N3 upper limit of normal or renal dysfunction (estimated glomerular filtration rate \<45 mL/min per 1.73m2) * Severe nervous system diseases * History of any malignancy or suffering from cancer * Lack of informed consent

What they're measuring

Change in Soluble suppression of tumourigenicity 2 (sST2,ng/ml)

Timeframe: from baseline to 12 weeks of treatment

2. Change in high-sensitivity C-reactive protein (hsCRP, mg/l )

Timeframe: Time Frame: from baseline to 12 weeks of treatment

Trial details

NCT IDNCT05637398

SponsorI.M. Sechenov First Moscow State Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-01