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

NCT06814990 | Recruiting

• 1 other identifier: 2024-3204-BO
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Chirrotic cardiomyopathy; Liver chirrosis; TIPS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Acquisition of right and left heart function parameters in patients before TIPS implantation

  1day before TIPS-Implantation

• Acquisition of right and left heart function parameters in patients after TIPS implantation

  1-3 days after TIPS-Implantation

• Acquisition of right and left heart function parameters in patients 3 Month after TIPS implantation

  about 3 month after TIPS-Implantation

• Acquisition of T1 and T2 mapping without contrast agent administration during the course

  1day before TIPS-Implantation to about 3 Month after

• Evaluation of changes in flow parameters in the aorta and pulmonary artery

  1day before TIPS-Implantation to about 3 Month after

Study Arms (1)

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

EXPERIMENTAL

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; Diagnostic Test: Blood samples; Diagnostic Test: Echocardiography

Interventions

Cardiac MRI DIAGNOSTIC_TEST

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.

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

Blood samples DIAGNOSTIC_TEST

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).

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

Echocardiography DIAGNOSTIC_TEST

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).

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stephanie Gräger: lead
• Jena University Hospital: collaborator

Study Sites (1)

Jena University Hospital

Jena, Thuringia, 07747, Germany

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis, Alcoholic; Fibrosis; Heart Failure

Interventions

Blood Specimen Collection; Echocardiography

Condition Hierarchy (Ancestors)

Liver Cirrhosis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Cardiac Imaging Techniques; Diagnostic Imaging; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Gräger

CONTACT

+4936419324800; stephanie.graeger@med.uni-jena.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Radiologist

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: February 7, 2025
• Study Start: April 19, 2024
• Primary Completion (Estimated): April 19, 2027
• Study Completion (Estimated): April 19, 2027
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)