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| Name | Class |
|---|---|
| Jena University Hospital | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Gräger | Contact | +4936419324800 | stephanie.graeger@med.uni-jena.de |
| Name | Affiliation | Role |
|---|---|---|
| Stephanie Gräger | Jena University Hospital | Principal Investigator |
| Stefanie Quickert | Jena University Hospital | Principal Investigator |
| René Aschenbach |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jena University Hospital | Recruiting | Jena | Thuringia | 07747 | Germany |
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|
| 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). |
|
| 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). |
|
| 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 |
| 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 |
| Jena University Hospital |
| Principal Investigator |
| Alexander Zipprich | Jena University Hospital | Principal Investigator |
| ID | Term |
|---|---|
| D008104 | Liver Cirrhosis, Alcoholic |
| D005355 | Fibrosis |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008108 | Liver Diseases, Alcoholic |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
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