Understanding the effects of a TIPS procedure on heart function

ISRCTN	ISRCTN69911855
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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Prof Jeanette Schulz-Menger
Principal investigator

Charité Universitätsmedizin Berlin, Campus Buch
Experimental and Clinical Research Center, Working Group on Cardiovascular Magnetic Resonance
Lindenberger Weg 80
Berlin
13125
Germany

ORCID ID	0000-0003-3100-1092
Phone	+49 (0)30 450553749
Email	jeanette.schulz-menger@charite.de

Dr Leonora Zange
Scientific

Charité Universitätsmedizin Berlin, Campus Buch
Experimental and Clinical Research Center, Working Group on Cardiovascular Magnetic Resonance
Lindenberger Weg 80
Berlin
13125
Germany

ORCID ID	0009-0006-6651-9106
Email	leonora.zange@charite.de

Mrs Elke Nickel-Szczech
Public

Charité Universitätsmedizin Berlin, Campus Buch
Experimental and Clinical Research Center, Working Group on Cardiovascular Magnetic Resonance
Lindenberger Weg 80
Berlin
13125
Germany

Email	elke.nickel-szczech@charite.de

Study information

Study design	Single-center non-interventional study
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
Age group	Adult
Lower age limit	18 Years
Sex	All
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

HELIOS Hospital Berlin-Buch

Schwanebecker Chaussee 50
Berlin
13125
Germany

Sponsor information

Charité - Universitätsmedizin Berlin
Hospital/treatment centre

Campus Berlin-Buch - ECRC
Working Group kardiale MRT
Lindenberger Weg 80
Berlin
13125
Germany

Phone	+49 (0)30 940152903
Email	jeanette.schulz-menger@charite.de
Website	https://www.charite.de
"ROR"	https://ror.org/001w7jn25

Funders

Funder type

Hospital/treatment centre

Charité – Universitätsmedizin Berlin
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
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.