Understanding the effects of a TIPS procedure on heart function
ISRCTN | ISRCTN69911855 |
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DOI | https://doi.org/10.1186/ISRCTN69911855 |
Secondary identifying numbers | 3000283 |
- Submission date
- 10/07/2025
- Registration date
- 27/08/2025
- Last edited
- 27/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
A transjugular intrahepatic portosystemic shunt (TIPS) procedure is used to lower high blood pressure in the veins of the liver, which can occur in people with liver cirrhosis. TIPS creates a new pathway that allows blood to bypass the liver and flow directly to the heart. As a result, the heart suddenly has to handle more blood than usual. In some cases, this extra strain can lead to heart failure, which may contribute to deaths after the procedure. This study aims to find out how the heart is affected before and after a TIPS procedure. We use cardiovascular magnetic resonance (CMR), which is the gold standard for measuring the size and function of the heart. Unlike standard heart ultrasound (echocardiography), CMR provides more detailed information about the heart’s structure.
Who can participate?
Patients with liver cirrhosis and portal hypertension who underwent cardiac evaluation before TIPS Implantation
What does the study involve?
Participants undergo a cardiac MRI scan before and 48 hours and 3 months after TIPS implantation.
What are the possible benefits and risks of participating?
Patients receive a detailed report about how their heart functions after the TIPS procedure. This information can help with their further medical care. In addition, by taking part in the study, patients actively contribute to improving medical knowledge and helping future patients with similar conditions.
MRI is in general a safe imaging technique that does not use radiation. However, certain risks must be considered. People with metal implants (like pacemakers) are excluded from the study as the strong magnetic field can interfere with or move metal objects. Patients receive a contrast agent (gadolinium), which is generally safe but can cause allergic reactions or, in rare cases, problems in people with poor kidney function, therefore, patients with severely reduced kidney functions did not receive contrast agents. The MRI machine is loud and enclosed, which can cause discomfort or claustrophobia in some patients. Overall, MRI is considered low-risk when proper safety checks are performed.
Where is the study run from?
Charité Universitätsmedizin Berlin (Germany)
When is the study starting and how long is it expected to run for?
October 2017 to June 2023
Who is funding the study?
Charité Universitätsmedizin Berlin (Germany)
Who is the main contact?
Prof. Dr. Jeanette Schulz-Menger, jeanette.schulz-menger@charite.de
Contact information
Principal Investigator
Charité Universitätsmedizin Berlin, Campus Buch
Experimental and Clinical Research Center, Working Group on Cardiovascular Magnetic Resonance
Lindenberger Weg 80
Berlin
13125
Germany
0000-0003-3100-1092 | |
Phone | +49 (0)30 450553749 |
jeanette.schulz-menger@charite.de |
Scientific
Charité Universitätsmedizin Berlin, Campus Buch
Experimental and Clinical Research Center, Working Group on Cardiovascular Magnetic Resonance
Lindenberger Weg 80
Berlin
13125
Germany
0009-0006-6651-9106 | |
leonora.zange@charite.de |
Public
Charité Universitätsmedizin Berlin, Campus Buch
Experimental and Clinical Research Center, Working Group on Cardiovascular Magnetic Resonance
Lindenberger Weg 80
Berlin
13125
Germany
elke.nickel-szczech@charite.de |
Study information
Study design | Single-center non-interventional study |
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Primary study design | Observational |
Secondary study design | Case series |
Study setting(s) | Hospital |
Study type | Diagnostic |
Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
Scientific title | Cardiac MRI evaluation on cardiac function and tissue in patients with liver cirrhosis compared to healthy volunteers and during follow-up after transjugular intrahepatic portosystemic shunt implantation |
Study acronym | TIPS-CMR |
Study objectives | Impact of transjugular intrahepatic portosystemic shunt (TIPS) on cardiac morphology, function and tissue properties |
Ethics approval(s) |
Approved 08/12/2017, Charité Ethics Committee (Charitéplatz 1, Berlin, 10117, Germany; 030/450-517222; ethikkommission@charite.de), ref: EA1/231/17 |
Health condition(s) or problem(s) studied | Liver cirrhosis and portal hypertension |
Intervention | Analysis of cardiac MRI in patients with liver cirrhosis and portal hypertension evaluated for transjugular intrahepatic portosystemic shunt (TIPS): pre-procedure assessment and short- and long-term follow-up after TIPS placement (48 hours and 3 months after TIPS implantation). |
Intervention type | Other |
Primary outcome measure | Left and right ventricle dimension measured using cardiac MRI before and 48 h and 3 months after TIPS implantation |
Secondary outcome measures | Left and right ventricle function, native T1-time, T2-time, extracellular volume (ECV) and fibrosis on late gadolinium enhancement (LGE) images measured using cardiac MRI before and 48 h and 3 months after TIPS implantation |
Overall study start date | 01/10/2017 |
Completion date | 23/06/2023 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 72 |
Total final enrolment | 45 |
Key inclusion criteria | Patients with liver cirrhosis and confirmed portal hypertension with indication for TIPS procedure (refractory ascites or gastrointestinal variceal bleeding) |
Key exclusion criteria | General contraindications to cardiac MRI (e.g. claustrophobic, metal implants) |
Date of first enrolment | 01/02/2018 |
Date of final enrolment | 30/07/2022 |
Locations
Countries of recruitment
- Germany
Study participating centre
Berlin
13125
Germany
Sponsor information
Hospital/treatment centre
Campus Berlin-Buch - ECRC
Working Group kardiale MRT
Lindenberger Weg 80
Berlin
13125
Germany
Phone | +49 (0)30 940152903 |
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jeanette.schulz-menger@charite.de | |
Website | https://www.charite.de |
https://ror.org/001w7jn25 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Medical School - Charité - University Medicine Berlin
- Location
- Germany
Results and Publications
Intention to publish date | 01/08/2025 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Stored in non-publicly available repository |
Publication and dissemination plan | Planned publication in a peer-reviewed journal |
IPD sharing plan | The datasets analysed during the current study will be stored in a non-publicly available repository (Working Group on Cardiovascular Magnetic Resonance, Experimental and Clinical Research Center, a joint cooperation between the Charité Medical Faculty and the Max-Delbrueck Center for Molecular Medicine ) |
Editorial Notes
10/07/2025: Study's existence confirmed by the Charité Ethics Committee.