Myocardial Fibrosis and Inflammation in Liver Cirrhosis

Portal Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05047029
• Other study ID #: 282/18_1
• Status: Completed
• Start date: November 2, 2018
• Est. completion date: September 8, 2021

Study information

• Verified date: September 2021
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 8, 2021
• Est. primary completion date: January 5, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cirrhosis, Liver
• Fibrosis
• Hypertension, Portal
• Inflammation
• Liver Cirrhosis
• Portal Hypertension

Intervention

Procedure:
• Transjugular intrahepatic portosystemic shunt implantation
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)

Diagnostic Test:
• Magnetic resonance imaging
Multiparametric cardiac and hepatic magnetic resonance imaging

Locations

Country	Name	City	State
Germany	University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology	Bonn	NRW
Germany	University Hospital Bonn, Medical Clinic and Polyclinic I	Bonn	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Isaak A, Praktiknjo M, Jansen C, Faron A, Sprinkart AM, Pieper CC, Chang J, Fimmers R, Meyer C, Dabir D, Thomas D, Trebicka J, Attenberger U, Kuetting D, Luetkens JA. Myocardial Fibrosis and Inflammation in Liver Cirrhosis: MRI Study of the Liver-Heart Axis. Radiology. 2020 Oct;297(1):51-61. doi: 10.1148/radiol.2020201057. Epub 2020 Aug 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.