Myocardial Fibrosis and Inflammation in Liver Cirrhosis

Completed

• Conditions: Cirrhosis, Liver; Cardiomyopathies; Portal Hypertension
• Interventions: Procedure: Transjugular intrahepatic portosystemic shunt implantation; Diagnostic Test: Magnetic resonance imaging

• Registration Number: NCT05047029
• Lead Sponsor: University Hospital, Bonn

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-02
• Primary Completion: 2021-01-05
• Status Verified: 2021-09
• Study Completion: 2021-09-08
• Study First Submitted: 2021-09-08
• Study First Submitted QC: 2021-09-08
• Last Update Submitted: 2021-09-08
• Study First Posted: 2021-09-16
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with cirrhosis	Transjugular intrahepatic portosystemic shunt implantation	Patients with cirrhosis and transjugular intrahepatic portosystemic shunt implantation.
Patients with cirrhosis	Magnetic resonance imaging	Patients with cirrhosis and transjugular intrahepatic portosystemic shunt implantation.

Primary Outcome Measures

Name	Time	Method
Myocardial T1 relaxation time	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 Outcome Measures

Name	Time	Method
Myocardial T2 relaxation time	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 \[ms\].
Myocardial ECV	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 \[%\].

Trial Locations

Locations (2)

University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology; 🇩🇪 Bonn, NRW, Germany

University Hospital Bonn, Medical Clinic and Polyclinic I; 🇩🇪 Bonn, NRW, Germany