Cirrhosis of Liver, Heart Decompensation, Liver Cirrhosis, Alcoholic, MASLD, TIPS
Conditions
Keywords
Chirrotic cardiomyopathy, Liver chirrosis, TIPS
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).
Interventions
DIAGNOSTIC_TESTCardiac 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_TESTBlood 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_TESTEchocardiography
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).
Sponsors
Stephanie Gräger
Jena University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of the frequency of occurrence of cardiac decompensation | From TIPSS to cardiac decompensation 12 Month | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acquisition of right and left heart function parameters in patients before TIPS implantation | 1day 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. |
| Acquisition of right and left heart function parameters in patients after TIPS implantation | 1-3 days 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. |
| Acquisition of right and left heart function parameters in patients 3 Month after TIPS implantation | about 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. |
| Acquisition of T1 and T2 mapping without contrast agent administration during the course | 1day before TIPS-Implantation to about 3 Month after | Detection of changes in T1 and T2-relaxation time in ms in MRI |
| Evaluation of changes in flow parameters in the aorta and pulmonary artery | 1day before TIPS-Implantation to about 3 Month after | Using newly implemented 4D Flow in MRI to observe changes in arterial flow and improve clinical usability of the sequence. |
| Follow-up of echocardiographic parameters and correlation with cardiac MRI | 1day before TIPS-Implantation to about 3 Month after | Observation of changes in cardiac function via echocardiography and subsequent comparison with cardiac MRI parameters |
| Correlation with laboratory markers (for inflammation, liver fibrosis, metabolism, cardiac remodeling) | 1day before TIPS-Implantation to about 6 Month after | 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). |
Countries
Germany
Contacts
CONTACTStephanie Gräger
PRINCIPAL_INVESTIGATORStephanie Gräger
Jena University Hospital
PRINCIPAL_INVESTIGATORStefanie Quickert
Jena University Hospital
PRINCIPAL_INVESTIGATORRené Aschenbach
Jena University Hospital
PRINCIPAL_INVESTIGATORAlexander Zipprich
Jena University Hospital
Outcome results
None listed