Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

HFpEF is a syndrome associated with high morbidity and mortality rates. The underlying mechanisms of the syndrome are not fully understood. Systemic low-grade inflammation is acknowledged to be a fundamental pathophysiological mechanism of HFpEF, which facilitates cardiomyocyte stiffness and myocardial fibrosis development. However, anti-inflammatory treatment approaches are largely under studied. Colchicine is a safe and well tolerated anti-inflammatory drug, which interferes with several steps in the inflammatory process, resulting in suppression of a number of pro-inflammatory pathways and cytokines release, including IL-1, hsCRP. The drug has been extensively studied in patients with coronary artery disease (COLCOT, LoDoCo2) and showed significant reduction in risk of cardio-vascular events, as well as inflammation. Post-hoc analysis of in the CANTOS study investigated the effect of monoclonal antibody targeting interleukin-1β in patients with prior myocardial infarction, showed a reduction in heart failure (HF) hospitalization of patients with elevations in high-sensitivity C-reactive protein (hsCRP). There is no data available regarding the effect of Colchicine on HFpEF patients. Soluble suppression of tumourigenicity 2 (sST2), a member of the interleukin (IL)-1 receptor family, which is not restricted to inflammation, but is also expressed in cardiomyocytes, fibroblast and endothelial cells of cardiac microvessels in response to myocardial stress antagonizing cardioprotective effects of IL-33/ST2 system. In HFpEF, sST2 associated with worse clinical signs and symptoms, co-morbidities, biomarkers of fibrosis and neurohormonal activation. Elevated levels of sST2 are acknowledged as a predictor of worse prognosis in both HF with reduced ejection fraction (HFrEF) and HFpEF. We assume that colchicine decreases inflammation and reduces sST2 levels in HFpEF. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05637398
Study type Interventional
Source I.M. Sechenov First Moscow State Medical University
Contact Anastasia SHCHENDRYGINA
Phone +79262309207
Email a.shchendrygina@gmail.com
Status Recruiting
Phase Phase 1/Phase 2
Start date December 15, 2022
Completion date November 1, 2024

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05038449 - Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19 N/A
Recruiting NCT04870424 - Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement Phase 3
Not yet recruiting NCT06215989 - Treatment of ACuTe Coronary Syndromes With Low-dose colchICine N/A
Terminated NCT04857931 - Colchicine in HFpEF Phase 2
Completed NCT03376698 - Dose-finding Study of Colchicine in Type 2 Diabetic Patients With Coronary Artery Disease Phase 2
Recruiting NCT05709509 - Effect of Colchicine on MMP-9, NOX2, and TGF-β1 in Myocardial Infarct Phase 4
Not yet recruiting NCT05361772 - Low-dose Colchicine Inhibit Abdominal Aortic Aneurysm Growth Trial N/A
Completed NCT05200052 - Effect of Colchicine On Left Ventricle Function After Anterior Myocardial Infarction Assessed By Speckle Tracking Phase 4