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NCT Number: NCT05047029

Myocardial Fibrosis and Inflammation in Liver Cirrhosis

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).

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Key information

Conditions

Cirrhosis, Liver Cardiomyopathies Cardiovascular Diseases Digestive System Diseases Fibrosis Heart Diseases Hypertension, Portal Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology, Bonn, North Rhine-Westphalia, Germany

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transjugular intrahepatic portosystemic shunt implantation

Procedure

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)

Magnetic Resonance Imaging

Diagnostic Test

Multiparametric cardiac and hepatic magnetic resonance imaging

Primary outcomes

  1. Myocardial T1 relaxation time

    Time frame: Change after 1 year of transjugular intrahepatic portosystemic shunt insertion.

    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].

Secondary outcomes

  1. Myocardial T2 relaxation time

    Time frame: Change after 1 year of transjugular intrahepatic portosystemic shunt insertion.

    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].

  2. Myocardial ECV

    Time frame: Change after 1 year of transjugular intrahepatic portosystemic shunt insertion.

    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 [%].

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 16, 2021
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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