NCT06814990

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Stephanie Gräger · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2024-04-19
• Primary completion: 2027-04-19
• Completion: 2027-04-19
• First posted: 2025-02-07
• Last updated: 2025-02-13

Locations

1 site across 1 country: Germany