Myocardial Fibrosis and Inflammation in Liver Cirrhosis

September 8, 2021 updated by: Julian Alexander Luetkens, University Hospital, Bonn

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with cirrhosis
Patients with cirrhosis and transjugular intrahepatic portosystemic shunt implantation.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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].
Change after 1 year of transjugular intrahepatic portosystemic shunt insertion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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].
Change after 1 year of transjugular intrahepatic portosystemic shunt insertion.
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 [%].
Change after 1 year of transjugular intrahepatic portosystemic shunt insertion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bonn

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2018

Primary Completion (Actual)

January 5, 2021

Study Completion (Actual)

September 8, 2021

Study Registration Dates

First Submitted

September 8, 2021

First Submitted That Met QC Criteria

September 8, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 8, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 282/18_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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