Clinical trial NCT06814990: Acquisition of Cardiac Function Parameters in MRI and Echocardiography in Patients with Ethyltoxic Liver Cirrhosis and Transjugular Intrahepatic Portosystemic Shunt (TIPSS) Placement
Official title: Erfassung Kardialer Funktionsparameter in MRT Und Echokardiographie Bei Patienten Mit Ethyltoxischer Leberzirrhose Und Transjugulärer Intrahepatischer Portosystemischer Shunt (TIPSS)-Anlage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: MASLD
Liver Cirrhosis, Alcoholic
Cirrhosis of Liver
Heart Decompensation
TIPS
Keywords: Chirrotic cardiomyopathy
Liver chirrosis
TIPS
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
Collaborators: name: Jena University Hospital
First posted: 2025-02-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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

Primary outcomes:
measure: Determination of the frequency of occurrence of cardiac decompensation
timeFrame: From TIPSS to cardiac decompensation 12 Month
Secondary outcomes:
measure: Acquisition of right and left heart function parameters in patients before TIPS implantation
timeFrame: 1day before TIPS-Implantation
measure: Acquisition of right and left heart function parameters in patients after TIPS implantation
timeFrame: 1-3 days after TIPS-Implantation
measure: Acquisition of right and left heart function parameters in patients 3 Month after TIPS implantation
timeFrame: about 3 month after TIPS-Implantation
measure: Acquisition of T1 and T2 mapping without contrast agent administration during the course
timeFrame: 1day before TIPS-Implantation to about 3 Month after
measure: Evaluation of changes in flow parameters in the aorta and pulmonary artery
timeFrame: 1day before TIPS-Implantation to about 3 Month after
measure: Follow-up of echocardiographic parameters and correlation with cardiac MRI
timeFrame: 1day before TIPS-Implantation to about 3 Month after
measure: Correlation with laboratory markers (for inflammation, liver fibrosis, metabolism, cardiac remodeling)
timeFrame: 1day before TIPS-Implantation to about 6 Month after
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Jena University Hospital
state: Thuringia
Study officials:
affiliation: Jena University Hospital
name: Stephanie Gräger
role: PRINCIPAL_INVESTIGATOR
affiliation: Jena University Hospital
name: Stefanie Quickert
role: PRINCIPAL_INVESTIGATOR
affiliation: Jena University Hospital
name: René Aschenbach
role: PRINCIPAL_INVESTIGATOR
affiliation: Jena University Hospital
name: Alexander Zipprich
role: PRINCIPAL_INVESTIGATOR
References: