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CompletedNCT05047029Updated Sep 16, 2021

Myocardial Fibrosis and Inflammation in Liver Cirrhosis

An observational study in Cirrhosis, Liver, Cardiomyopathies and Portal Hypertension, sponsored by University Hospital, Bonn. Completed at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-16.

Sponsored by University Hospital, Bonn · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
13
Ages
18 Years and older
Sex
All
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Study 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).

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Conditions studied

  • Cirrhosis, Liver
  • Cardiomyopathies
  • Portal Hypertension
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In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's enrollment of 13 is below the median of 151 across 587 observational studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

University Hospital, Bonn is the lead sponsor of 154 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Primary care clinic (Department of Internal Medicine I, University Hospital Bonn, Germany)

Inclusion criteria

  • liver cirrhosis with evaluation of TIPS implantation
  • patients who are 18 years of age or older

Exclusion criteria

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
13 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with cirrhosis

    Patients with cirrhosis and transjugular intrahepatic portosystemic shunt implantation.

    Procedure: Transjugular intrahepatic portosystemic shunt implantation · Diagnostic Test: Magnetic resonance imaging

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

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What researchers measure

Primary outcomes

  1. 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 \[ms\].

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

Secondary outcomes

  1. 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 \[ms\].

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

  2. 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 \[%\].

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

07

Study locations

2 sites
  • University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology
    Bonn, NRW 53127, Germany
  • University Hospital Bonn, Medical Clinic and Polyclinic I
    Bonn, NRW 53127, Germany
08

References and documents

Publications

  • 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. PubMed 32808886 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05047029
Lead sponsor
University Hospital, Bonn
Responsible party
Julian Alexander Luetkens (Prinicipal Investigator, Senior Physician, University Hospital, Bonn) — Principal investigator
First posted
Sep 16, 2021
Start date
Nov 2, 2018
Primary completion
Jan 5, 2021
Completion
Sep 8, 2021
Last update
Sep 16, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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