Myocardial Fibrosis and Inflammation in Liver Cirrhosis

Study Overview
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Brief Summary
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The aim of this clinical prospective study is to assess structural and functional myocardial changes in patients with liver cirrhosis after implantation of transjugular intrahepatic portosystemic shunt (TIPS).

Official Title
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Multiparametric Magnetic Resonance Imaging in Patients With Liver Cirrhosis for Evaluation of Myocardial Fibrosis and Inflammation in Cirrhotic Cardiomyopathy

Conditions
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Cirrhosis, Liver, Cardiomyopathies, Portal Hypertension

Intervention / Treatment
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* Procedure: Transjugular intrahepatic portosystemic shunt implantation
* Diagnostic Test: Magnetic resonance imaging


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: liver cirrhosis with evaluation of TIPS implantation patients who are 18 years of age or older Exclusion criteria: underlying cardiac disease, e.g. known myocardial infarction, previous myocarditis, congenital heart disease, cardiomyopathies of other causes known underlying disease witt potential cardiac involvement, e.g. storage disease (e.g. hemochromatosis, Fabry disease), inflammatory (e.g. sarcoidosis), endocrinological (e.g. diabetes mellitus, hyper-/hypothyroidism), autoimmune (e.g. systemic lupus erythematosus, dermatomyositis, rheumatoid arthritis), therapeutic (chemotherapy). patients with contraindication for contrast-enhanced MRI pregnant and breastfeeding women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with cirrhosis<br>Patients with cirrhosis and transjugular intrahepatic portosystemic shunt implantation. | Procedure: Transjugular intrahepatic portosystemic shunt implantation<br>* Transjugular intrahepatic portosystemic shunt is an artificial channel within the liver that establishes communication between the inflow portal vein and the outflow hepatic vein. It is used to treat portal hypertension (e.g., in liver cirrhosis)<br>Diagnostic Test: Magnetic resonance imaging<br>* Multiparametric cardiac and hepatic magnetic resonance imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial T1 relaxation time | T1 relaxation times will be obtained to asses acute myocardial injury and fibrosis. T1 maps will be analyzed using a segmental approach by region of interest analysis. T1 relaxation times are given in [ms]. | Change after 1 year of transjugular intrahepatic portosystemic shunt insertion. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial T2 relaxation time | T2 relaxation times will be obtained to asses myocardial edema. T2 maps will be analyzed using a segmental approach by region of interest analysis. T2 relaxation times are given in [ms]. | Change after 1 year of transjugular intrahepatic portosystemic shunt insertion. | 
| Myocardial ECV | Myocardial extracellular volume will be obtained to asses extracellular space/myocardial fibrosis. ECV values will be calculated using a segmental approach by region of interest analysis of native and contrast-enhanced T1 relaxation maps. ECV values are given in [%]. | Change after 1 year of transjugular intrahepatic portosystemic shunt insertion. |