Actively Recruiting
Acquisition of Cardiac Function Parameters Using MRI and Echocardiography in Patients with Alcoholic Liver Cirrhosis Undergoing Transjugular Intrahepatic Portosystemic Shunt (TIPSS) Placement
Led by Stephanie Gräger · Updated on 2025-02-13
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Stephanie Gräger
Lead Sponsor
J
Jena University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The trial investigates the development of cardiac decompensation in patients with ethyltoxic liver cirrhosis who undergo transjugular intrahepatic portosystemic shunt (TIPSS) implantation. It aims to determine how often cardiac decompensation occurs within one year and to identify associated laboratory, clinical, or imaging changes. This research evaluates these risks to improve future treatment decisions and selection criteria for TIPSS implantation. Participants will receive three additional cardiac magnetic resonance imaging (MRI) scans with measurements of cardiac function, T1 and T2 relaxation times, and 4D-Flow sequences assessing aortic and pulmonary artery flow. Extended echocardiographic exams will be conducted before, 3 days after, and 3 months after TIPSS implantation. Blood samples will be collected at multiple time points before and after the procedure to analyze inflammatory, endothelial, and cardiac remodeling markers. During the study, participants will undergo standardized clinical TIPSS implantation alongside detailed cardiac assessments including MRI and echocardiography. Researchers will monitor right and left heart function, flow parameters, and laboratory markers for up to 12 months. The main outcome measure is the frequency of cardiac decompensation over one year. Secondary outcomes include heart function changes and correlations with laboratory markers. Safety and clinical status will be closely observed throughout the study period.
CONDITIONS
Brief Title
Acquisition of Cardiac Function Parameters in MRI and Echocardiography in Patients with Ethyltoxic Liver Cirrhosis and Transjugular Intrahepatic Portosystemic Shunt (TIPSS) Placement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 99 years
- Written informed consent of the patient
- Diagnosis of decompensated liver cirrhosis by clinical, imaging, or laboratory criteria
- Patient scheduled for elective TIPSS implantation in appropriate clinical context
You will not qualify if you...
- Pregnancy
- Implants not compatible with magnetic resonance imaging (MRI)
- Medical or personal reasons preventing MRI (e.g., claustrophobia, inability to lie flat, or follow breathing commands)
- Patient in critical condition or noncompliant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From 1 day before TIPSS implantation to about 3 months after TIPSS implantation
Participants undergo cardiac magnetic resonance imaging (MRI) and extended echocardiography to acquire cardiac function parameters, along with blood sample collection for specialized laboratory analyses.
3 visits (1 day before, 1-3 days after, and about 3 months after TIPSS implantation)
Duration - Up to 6 months after TIPSS implantation
Participants are followed for up to 6 months after TIPSS implantation for correlation of echocardiographic and MRI parameters with laboratory markers related to inflammation, liver fibrosis, metabolism, and cardiac remodeling.
Follow-up visits as scheduled up to 6 months
Trial Site Locations
Total: 1 location
1
Jena University Hospital
Jena, Thuringia, Germany, 07747
Actively Recruiting
Research Team
S
Stephanie Gräger
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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