Acquisition of Cardiac Function Parameters in MRI and Echocardiography in Patients With Ethyltoxi… (NCT06814990) | Clinical Trial Compass
RecruitingNot Applicable
Acquisition of Cardiac Function Parameters in MRI and Echocardiography in Patients With Ethyltoxic Liver Cirrhosis and Transjugular Intrahepatic Portosystemic Shunt (TIPSS) Placement
Germany80 participantsStarted 2024-04-19
Plain-language summary
The aim of this clinical trial is to investigate the development of cardiac decompensation following transjugular intrahepatic portosystemic shunt (TIPSS) implantation in order to draw conclusions for future treatment methods or exclusion criteria prior to TIPS implantation.
The main questions to be answered are:
How often do symptoms of cardiac decompensation develop over a one year period? What laboratory, clinical or imaging morphological changes are associated with this? In addition to the standardised clinical procedure for TIPSS implantation, participants will undergo 3 cardiac magnetic resonance imaging (MRI), extended echocardiographic examinations (both just before, 3 days after and 3 months after implantation) and laboratory chemistry tests for specific endothelial and inflammatory markers (just before, on the day of implantation, 1 day after, 1, 3, 6 and 12 months after implantation).
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 to 99 years
* Written informed consent of the patient
* Decompensated liver cirrhosis, defined by clinical, imaging or laboratory criteria
* Patient receives an elective TIPSS in the appropriate clinical context at the JUH
Exclusion Criteria:
* Pregnancy
* Implants not suitable for magnetic resonance imaging
* Medical/personal reasons against magnetic resonance imaging (claustrophobia, patient cannot lie flat or follow breathing commands)
* Patient in critical condition or incompliant
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is specifically looking at patients with alcohol-related liver cirrhosis who are having a TIPS procedure — does my specific type of cirrhosis and my planned or past TIPS placement make this worth discussing as a potential fit with my care team?
2The trial is measuring how often heart decompensation occurs after TIPS placement — does my heart function currently show any signs that would make this kind of monitoring especially important for my situation?
3Since this study involves both MRI and echocardiography to look at heart function, what would that testing schedule actually involve in terms of time, appointments, and physical demands on top of my existing treatment?
4TIPS procedures are known to sometimes put extra strain on the heart — would participating in this observational study give me access to closer cardiac monitoring than I would otherwise receive as part of my standard care?
5Given that this trial is in an early, non-phase stage focused on measuring how often a problem occurs rather than testing a treatment, should I be pursuing any separate interventions for my heart or liver health while this kind of research is still ongoing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determination of the frequency of occurrence of cardiac decompensation
Timeframe: From TIPSS to cardiac decompensation 12 Month