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Recruiting NCT06814990

Acquisition of Cardiac Function Parameters in MRI and Echocardiography in Patients With Ethyltoxic Liver Cirrhosis and Transjugular Intrahepatic Portosystemic Shunt (TIPSS) Placement

Conditions: MASLD, Liver Cirrhosis, Alcoholic, Cirrhosis of Liver, Heart Decompensation, TIPS

Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Stephanie Gräger

Location: Jena University Hospital Jena Thuringia

Summary

The aim of this clinical trial is to investigate the development of cardiac decompensation following transjugular intrahepatic portosystemic shunt (TIPSS) implantation in order to draw conclusions for future treatment methods or exclusion criteria prior to TIPS implantation. The main questions to be answered are: How often do symptoms of cardiac decompensation develop over a one year period? What laboratory, clinical or imaging morphological changes are associated with this? In addition to the standardised clinical procedure for TIPSS implantation, participants will undergo 3 cardiac magnetic resonance imaging (MRI), extended echocardiographic examinations (both just before, 3 days after and 3 months after implantation) and laboratory chemistry tests for specific endothelial and inflammatory markers (just before, on the day of implantation, 1 day after, 1, 3, 6 and 12 months after implantation).

Eligibility Criteria

Inclusion Criteria: * Age 18 to 99 years * Written informed consent of the patient * Decompensated liver cirrhosis, defined by clinical, imaging or laboratory criteria * Patient receives an elective TIPSS in the appropriate clinical context at the JUH Exclusion Criteria: * Pregnancy * Implants not suitable for magnetic resonance imaging * Medical/personal reasons against magnetic resonance imaging (claustrophobia, patient cannot lie flat or follow breathing commands) * Patient in critical condition or incompliant

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06814990). StuddyBuddy aggregates publicly available trial information.