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Erfassung Kardialer Funktionsparameter in MRT Und Echokardiographie Bei Patienten Mit Ethyltoxischer Leberzirrhose Und transjugulärer Intrahepatischer Portosystemischer Shunt (TIPSS)-Anlage

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Jena University Hospital
RECRUITING
Jena
Contact Information
Primary
Stephanie Gräger
stephanie.graeger@med.uni-jena.de
+4936419324800
Time Frame
Start Date: 2024-04-19
Estimated Completion Date: 2027-04-19
Participants
Target number of participants: 80
Treatments
Experimental: Measurements of cardiac function in MRI and echocardiography, additional laboratory work
Patients in this arm will receive three additional cardiac magnetic resonance imaging (MRI) scans with acquisition of cardiac function parameters, T1 and T2 relaxation time measurements and a newly introduced 4D-Flow sequence to assess changes in aortic and pulmonary artery flow. These patients will also receive extended echocardiography with additional parameters to diagnose cirrhotic cardiomyopathy. We will also analyse specific blood parameters that are not yet part of the clinical standard.
Sponsors
Collaborators: Jena University Hospital
Leads: Stephanie Gräger

This content was sourced from clinicaltrials.gov