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Myocardial Fibrosis and Inflammation in Liver Cirrhosis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05047029
Enrollment
13
Registered
2021-09-16
Start date
2018-11-02
Completion date
2021-09-08
Last updated
2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathies, Cirrhosis, Liver, Portal Hypertension

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).

Interventions

PROCEDURETransjugular 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_TESTMagnetic resonance imaging

Multiparametric cardiac and hepatic magnetic resonance imaging

Sponsors

University Hospital, Bonn
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Myocardial T1 relaxation timeChange 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

MeasureTime frameDescription
Myocardial T2 relaxation timeChange 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 ECVChange 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 \[%\].

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026