NCT05047029

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

2.2 years

First QC Date

September 8, 2021

Last Update Submit

September 8, 2021

Conditions

Cirrhosis, LiverCardiomyopathiesPortal Hypertension

Outcome Measures

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 \[ms\].

    Change after 1 year of transjugular intrahepatic portosystemic shunt insertion.

Secondary Outcomes (2)

  • Myocardial T2 relaxation time

    Change after 1 year of transjugular intrahepatic portosystemic shunt insertion.

  • Myocardial ECV

    Change after 1 year of transjugular intrahepatic portosystemic shunt insertion.

Study Arms (1)

Patients with cirrhosis

Patients with cirrhosis and transjugular intrahepatic portosystemic shunt implantation.

Procedure: Transjugular intrahepatic portosystemic shunt implantationDiagnostic Test: Magnetic resonance imaging

Interventions

Transjugular intrahepatic portosystemic shunt implantationPROCEDURE

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)

Patients with cirrhosis
Magnetic resonance imagingDIAGNOSTIC_TEST

Multiparametric cardiac and hepatic magnetic resonance imaging

Patients with cirrhosis

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology

Bonn, North Rhine-Westphalia, 53127, Germany

Location

University Hospital Bonn, Medical Clinic and Polyclinic I

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Related 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.

    PMID: 32808886BACKGROUND

MeSH Terms

Conditions

Liver CirrhosisCardiomyopathiesHypertension, Portal

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator, Senior Physician

Study Record Dates

First Submitted

September 8, 2021

First Posted

September 16, 2021

Study Start

November 2, 2018

Primary Completion

January 5, 2021

Study Completion

September 8, 2021

Last Updated

September 16, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)