Assessing heart function in patients with liver cirrhosis undergoing TIPSS placement
Erfassung Kardialer Funktionsparameter in MRT Und Echokardiographie Bei Patienten Mit Ethyltoxischer Leberzirrhose Und Transjugulärer Intrahepatischer Portosystemischer Shunt (TIPSS)-Anlage
This study is testing how heart function changes in patients with severe liver cirrhosis who are getting a specific procedure called TIPSS to see if it affects their heart health over the next year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Jena University Hospital Academic / other |
| Locations | 1 site (Jena, Thuringia) |
| Trial ID | NCT06814990 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the development of cardiac decompensation in patients with decompensated liver cirrhosis who are undergoing transjugular intrahepatic portosystemic shunt (TIPSS) implantation. Participants will undergo cardiac magnetic resonance imaging (MRI) and echocardiographic examinations at various intervals before and after the procedure, along with laboratory tests to monitor specific markers. The study aims to identify the frequency of cardiac symptoms and associated changes over a one-year period, which could inform future treatment protocols and patient selection criteria for TIPSS. By closely monitoring these patients, the research seeks to enhance understanding of the cardiac implications of liver cirrhosis and TIPSS.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 99 with decompensated liver cirrhosis who are scheduled for elective TIPSS implantation.
Not a fit: Patients who are pregnant, have incompatible implants for MRI, or are in critical condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with liver cirrhosis and reduce the risk of cardiac complications following TIPSS placement.
How similar studies have performed: While the specific approach of this study may be novel, similar studies have indicated the importance of monitoring cardiac function in patients with liver disease, suggesting potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Jena, Thuringia
- Jena University Hospital — Jena, Thuringia, Germany (Recruiting)
Study contacts
- Principal investigator: Stephanie Gräger — Jena University Hospital
- Study coordinator: Stephanie Gräger
- Email: stephanie.graeger@med.uni-jena.de
- Phone: +4936419324800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.