drugset / Trial / NCT05637398

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

NCT05637398

Phase 1/2 Completed 42 enrolled I.M. Sechenov First Moscow State Medical University
RandomizedCrossoverSingle-blindTreatment

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.

Timeline

Start
2022-12-15
Primary completion
2025-09-01
Completion
2025-09-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Colchicine Small molecule 0.5 mg

Indications