Acquisition of Cardiac Function Parameters in MRI and Echocardiography in Patients With Ethyltoxic Liver Cirrhosis and Transjugular Intrahepatic Portosystemic Shunt (TIPSS) Placement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cardiac MRI, Blood samples, Echocardiography.
- Who it may be relevant to
- Registry conditions: MASLD, Liver Cirrhosis, Alcoholic, Cirrhosis of Liver, Heart Decompensation. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Erfassung Kardialer Funktionsparameter in MRT Und Echokardiographie Bei Patienten Mit Ethyltoxischer Leberzirrhose Und transjugulärer Intrahepatischer Portosystemischer Shunt (TIPSS)-Anlage
Overview
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).
Interventions
- 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 pulmonar - 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, choleste - 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).
Primary outcome measures
- Determination of the frequency of occurrence of cardiac decompensation [Time frame: From TIPSS to cardiac decompensation 12 Month]
Secondary outcome measures (7)
- Acquisition of right and left heart function parameters in patients before TIPS implantation [Time frame: 1day before TIPS-Implantation]
- Acquisition of right and left heart function parameters in patients after TIPS implantation [Time frame: 1-3 days after TIPS-Implantation]
- Acquisition of right and left heart function parameters in patients 3 Month after TIPS implantation [Time frame: about 3 month after TIPS-Implantation]
- Acquisition of T1 and T2 mapping without contrast agent administration during the course [Time frame: 1day before TIPS-Implantation to about 3 Month after]
- Evaluation of changes in flow parameters in the aorta and pulmonary artery [Time frame: 1day before TIPS-Implantation to about 3 Month after]
- Follow-up of echocardiographic parameters and correlation with cardiac MRI [Time frame: 1day before TIPS-Implantation to about 3 Month after]
- Correlation with laboratory markers (for inflammation, liver fibrosis, metabolism, cardiac remodeling) [Time frame: 1day before TIPS-Implantation to about 6 Month after]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Germany · 1 center
- Jena University Hospital — Jena
Identifiers
NCT: NCT06814990 · 2024-3204-BO