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

Stephanie Gräger

Status: Enrolling

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

Treatments: Diagnostic Test: Cardiac MRI; Diagnostic Test: Blood samples; Diagnostic Test: Echocardiography

Study type: Interventional

Funder types: Other

Identifiers

NCT06814990

2024-3204-BO

Details and patient eligibility

About

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).

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Measurements of cardiac function in MRI and echocardiography, additional laboratory work

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Echocardiography

Diagnostic Test: Blood samples

Diagnostic Test: Cardiac MRI