Pharmacokinetic Modelling of Levosimendan in Adults

In the light of current knowledge of the PK of levosimendan and its use in ECMO weaning, deciphering the mechanisms of inter-individual variability in exposure and response to levosimendan appears essential in order to better stratify patients eligible or not for this therapy and to adapt the treatment of patients in cardiogenic shock, with or without ECMO support, accordingly. The aim of this project is to use an innovative pharmacokinetic modelling approach based on clinico-biological data to study the key factors that could contribute to treatment failure in cardiogenic shock and to integrate them quantitatively for dose individualisation. The aim of this project is to conduct a prospective, multicentre, observational, comparative analysis, with minimal risks and constraints, to determine the concentrations of levosimendan and its metabolites during patient management in order to develop a pharmacokinetic model.

NCT Number	NCT06993584
Lead Sponsor	University Hospital, Rouen Collaborators: University Hospital, Lille, Amiens University Hospital, France
Conditions	Cardiogenic Shock
Enrollment	100 participants
Start Date	2025-07-01
Primary Completion	2027-07-30 (estimated)
Study Completion	2027-08-31 (estimated)
Updated on ClinicalTrials.gov	2025-06-27