Cirrhosis, LiverNCT05047029
Myocardial Fibrosis and Inflammation in Liver Cirrhosis
An observational study of Cirrhosis, Liver and Cardiomyopathies, run by University Hospital, Bonn at 2 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver, Cardiomyopathies, Portal Hypertension
- What is being tested?
- Transjugular intrahepatic portosystemic shunt implantation and Magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- 2 sitesGermany
- Study dates
- 2 Nov 2018to 8 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Primary care clinic (Department of Internal Medicine I, University Hospital Bonn, Germany)
Who may be able to join
- liver cirrhosis with evaluation of TIPS implantation
- patients who are 18 years of age or older
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology
Bonn, North Rhine-Westphalia, 53127
University Hospital Bonn, Medical Clinic and Polyclinic I
Bonn, North Rhine-Westphalia, 53127
About this study
Official title: 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).
- Conditions
- Cirrhosis, Liver, Cardiomyopathies, Portal Hypertension
- Being tested
- Transjugular intrahepatic portosystemic shunt implantation, Magnetic resonance imaging
- Medical subject headings
- Liver Cirrhosis, Cardiomyopathies, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transjugular intrahepatic portosystemic shunt implantationProcedure or surgery
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)
Magnetic resonance imagingDiagnostic test
Multiparametric cardiac and hepatic magnetic resonance imaging
| Study group | Role | What they receive |
|---|---|---|
| Patients with cirrhosis | Patients with cirrhosis and transjugular intrahepatic portosystemic shunt implantation. Receives: Procedure: Transjugular intrahepatic portosystemic shunt implantation; Diagnostic Test: Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: Change after 1 year of transjugular intrahepatic portosystemic shunt insertion.
Secondary outcomes (2)
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].
Measured: Change after 1 year of transjugular intrahepatic portosystemic shunt insertion.
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 [%].
Measured: Change after 1 year of transjugular intrahepatic portosystemic shunt insertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start2 Nov 2018
- Primary completion5 Jan 2021
- Study completion8 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julian Alexander Luetkens, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047029
- Sponsor's protocol ID
- 282/18_1
- Status last verified
- Sep 2021
- First submitted
- 8 Sep 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric Magnetic Resonance Imaging in Patients With Liver Cirrhosis for Evaluation of Myocardial Fibrosis and Inflammation in Cirrhotic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT05047029
- Acronym / sponsor ID
- 282/18_1
- Conditions
- Cirrhosis, Liver, Cardiomyopathies, Portal Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 5 Jan 2021 (actual)
- Study completion
- 8 Sep 2021 (actual)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cirrhosis | – | Procedure: Transjugular intrahepatic portosystemic shunt implantation, Diagnostic Test: Magnetic resonance imagingPatients with cirrhosis and transjugular intrahepatic portosystemic shunt implantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic (Department of Internal Medicine I, University Hospital Bonn, Germany)
Key inclusion criteria (2 listed)
- liver cirrhosis with evaluation of TIPS implantation
- patients who are 18 years of age or older
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transjugular intrahepatic portosystemic shunt implantationTransjugular 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) | Procedure or surgery | Patients with cirrhosis |
| Magnetic resonance imagingMultiparametric cardiac and hepatic magnetic resonance imaging | Diagnostic test | Patients with cirrhosis |
Primary outcome
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].
2 secondary outcomes
Myocardial T2 relaxation time
Time frame: Change after 1 year of transjugular intrahepatic portosystemic shunt insertion.
Myocardial ECV
Time frame: Change after 1 year of transjugular intrahepatic portosystemic shunt insertion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Background: PubMed 32808886Isaak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, Liver and Cardiomyopathies, run by University Hospital, Bonn at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial T1 relaxation time (time frame: Change after 1 year of transjugular intrahepatic portosystemic shunt insertion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05047029, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.