Pharmacokinetic Modelling of Levosimendan in Adults

Launched by UNIVERSITY HOSPITAL, ROUEN · May 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called levosimendan, which is used to treat patients experiencing cardiogenic shock after a heart attack. Cardiogenic shock is a serious condition where the heart can't pump enough blood to meet the body’s needs. The researchers want to understand how different factors affect how well patients respond to levosimendan, so they can personalize the treatment for each individual. By analyzing data from multiple hospitals, they aim to develop a model that helps determine the best dose of levosimendan for different patients.

To be eligible for this trial, participants must be between 18 and 75 years old, weigh at least 50 kilograms, and be admitted to an intensive care unit with severe heart problems. The medical team must plan to start levosimendan treatment as part of their care. Patients will be closely monitored during their treatment, and their consent will be obtained for using their data in the study. This trial is not yet recruiting participants, and it will involve minimal risks and constraints for those who choose to take part.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient between 18 and 75 years of age admitted to an intensive care unit,
• • Weight ≥ 50 kg,
• • Patient with cardiogenic shock defined by a SCAI stage C, D, or E score.
• • The medical team plans to initiate LVSMD treatment as part of the management of cardiogenic shock, according to the recommendations in the Summary of Product Characteristics (SmPC),
• • Expected life expectancy \> 48 hours,
• • Patient affiliated with a social security scheme,
• • Due to the life-threatening nature of cardiogenic shock, the patient or, where applicable, family members or trusted person are informed as soon as possible and their consent is requested for the possible continuation of this research. They may also object to the use of the patient's data (and blood samples) for this research.
• Exclusion Criteria:
• • Pregnant, childbearing, or breastfeeding women,
• • Persons deprived of their liberty by an administrative or judicial decision, or persons placed under judicial protection/guardianship or curatorship.