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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Heart Decompensation; Liver Cirrhosis, Alcoholic; Cirrhosis of Liver; TIPS; MASLD
• Intervention / Treatment: Diagnostic test: Cardiac MRI; Diagnostic test: Blood samples; Diagnostic test: Echocardiography

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie Gräger; Phone Number: +4936419324800; Email: stephanie.graeger@med.uni-jena.de

Study Locations

• Germany
  • Thuringia
    • Jena, Thuringia, Germany, 07747
      • Recruiting
      • Jena University Hospital
      • Contact: Stephanie Gräger; Phone Number: +4936419324856; Email: stephanie.graeger@med.uni-jena.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Diagnostic test: Cardiac MRI; Additional to standard clinical practice Patients will receive a cardiac magnetic resonance imaging without contrast. Measured parameters are enddoastolic and endsystolic volume (in ml oder ml/body surface area (BSA)), stroke volume (in ml) of right and left ventricle absolute and relatvie to body surface area (BSA), ejection fraction in % of right and left ventricle, myocardial Strain in % of right and left ventricle if applicable. T1 and T2 relaxation times are obtained and aortic and pulmonary artery flow parameters are measured.; Diagnostic test: Blood samples; We will take additional blood samples for the analysis of markers of bacterial translocation (e.g. LBP, EndoCAb, 16S rRNA), detection of bacterial markers (bacterial extracellular vesicles), inflammatory markers (e.g. IL-1ß, TNF-α, TGF-ß, IL-6, CXCL8, IL1-RA, IL-10, IL-18) and monocyte/macrophage activation markers (sCD14, sCD163, sCD87, sCD206), bile acids (including TCA, GCA, GCDCA, TCDCA, TLCA, GLCA, TDCA, GDCA, CA, CDCA, UDCA, DCA, TUDCA, LCA), lipids and lipoproteins (triglyerides, cholesterol, LDL/HDL cholesterol), coagulation factors (e.g. VWF, ADAMTS13, fibrinogen), markers of cardiac remodeling (e.g. NT-proBNP; troponin, VEGF-D, cleaved Gasdermin D, HMGB1) and Immunophenotyping of monocytes/macrophages, T and B cells (e.g. CD14, CD16, MERTK, CD4, CD127, CD25, TREM1/2).; Diagnostic test: Echocardiography; Patients will receive an extended echocardiographic protocol. In addition to standard clinical parameters, we will collect study specific parameters such as LV EF in %, global longitudinal strain in %, septal e' velocity (cm/s), E/e' ratio, left atrial volume index (LAVI) (in ml/m2), tricuspid regurgitation velocities (m/s).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of the frequency of occurrence of cardiac decompensation	Cardiac decompensation is defined as one or a collection of the following new symptoms: Fatigue, Dyspnoea, Edema, jugular vein congestion, elevated pro-BNP, restricted heart function in echocardiography, clinically indicated chest x-ray with edema or pleura effusion. Clinical evaluation and diagnostic methods according to clinical standard are applied (e.g. x-ray and ultrasound if clinically needed).	From TIPSS to cardiac decompensation 12 Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acquisition of T1 and T2 mapping without contrast agent administration during the course	Detection of changes in T1 and T2-relaxation time in ms in MRI	1day before TIPS-Implantation to about 3 Month after
Evaluation of changes in flow parameters in the aorta and pulmonary artery	Using newly implemented 4D Flow in MRI to observe changes in arterial flow and improve clinical usability of the sequence.	1day before TIPS-Implantation to about 3 Month after
Follow-up of echocardiographic parameters and correlation with cardiac MRI	Observation of changes in cardiac function via echocardiography and subsequent comparison with cardiac MRI parameters	1day before TIPS-Implantation to about 3 Month after
Correlation with laboratory markers (for inflammation, liver fibrosis, metabolism, cardiac remodeling)	Correlation of clinical and imaging parameters with different blood markers which are aquired to clinical standard (Serum sodium, Quick, INR, pTT, Crea, urea, albumin, CRP, ALAT, ASAT, Bili, venous pH, LDH, lactate, glucose, complete blood count) and study specific (markers of bacterial translocation (e.g. LBP, EndoCAb, 16S rRNA), detection of bacterial markers (bacterial extracellular vesicles), inflammatory markers (e.g. IL-1ß, TNF-α, TGF-ß, IL-6, CXCL8, IL1-RA, IL-10, IL-18) and monocyte/macrophage activation markers (sCD14, sCD163, sCD87, sCD206), bile acids (including TCA, GCA, GCDCA, TCDCA, TLCA, GLCA, TDCA, GDCA, CA, CDCA, UDCA, DCA, TUDCA, LCA), lipids and lipoproteins (triglyerides, cholesterol, LDL/HDL cholesterol), coagulation factors (e.g. VWF, ADAMTS13, fibrinogen), markers of cardiac remodeling (e.g. NT-proBNP; troponin, VEGF-D, cleaved Gasdermin D, HMGB1) and Immunophenotyping of monocytes/macrophages, T and B cells (e.g. CD14, CD16, MERTK, CD4, CD127, CD25, TREM1/2).	1day before TIPS-Implantation to about 6 Month after
Acquisition of right and left heart function parameters in patients before TIPS implantation	Monitoring changes in cardiac function using cardiac MRI. Measured parameters are end diastolic and end systolic volumes (in ml or ml/BSA), stroke volume (in ml) of the right and left ventricle absolute and relative to body surface area (BSA), ejection fraction in percent of the right and left ventricle, myocardial strain in percent of the right and left ventricle if applicable.	1day before TIPS-Implantation
Acquisition of right and left heart function parameters in patients after TIPS implantation	Monitoring changes in cardiac function using cardiac MRI. Measured parameters are end diastolic and end systolic volumes (in ml or ml/BSA), stroke volume (in ml) of the right and left ventricle absolute and relative to body surface area (BSA), ejection fraction in percent of the right and left ventricle, myocardial strain in percent of the right and left ventricle if applicable.	1-3 days after TIPS-Implantation
Acquisition of right and left heart function parameters in patients 3 Month after TIPS implantation	Monitoring changes in cardiac function using cardiac MRI. Measured parameters are end diastolic and end systolic volumes (in ml or ml/BSA), stroke volume (in ml) of the right and left ventricle absolute and relative to body surface area (BSA), ejection fraction in percent of the right and left ventricle, myocardial strain in percent of the right and left ventricle if applicable.	about 3 month after TIPS-Implantation

Collaborators and Investigators

• Sponsor: Stephanie Gräger
• Collaborators: Jena University Hospital
• Investigators: Principal Investigator: Stephanie Gräger, Jena University Hospital; Principal Investigator: Stefanie Quickert, Jena University Hospital; Principal Investigator: René Aschenbach, Jena University Hospital; Principal Investigator: Alexander Zipprich, Jena University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2024
• Primary Completion (Estimated): April 19, 2027
• Study Completion (Estimated): April 19, 2027

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): February 7, 2025

Study Record Updates

• Last Update Posted (Actual): August 4, 2026
• Last Update Submitted That Met QC Criteria: August 3, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: TIPS; Chirrotic cardiomyopathy; Liver chirrosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Digestive System Diseases; Liver Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Liver Cirrhosis; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Pathological Conditions, Signs and Symptoms; Heart Failure; Fibrosis; Liver Cirrhosis, Alcoholic; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Diagnostic Imaging; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Cardiac Imaging Techniques; Ultrasonography; Blood Specimen Collection; Echocardiography
• Other Study ID Numbers: 2024-3204-BO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No