Erfassung Kardialer Funktionsparameter in MRT Und Echokardiographie Bei Patienten Mit Ethyltoxischer Leberzirrhose Und transjugulärer Intrahepatischer Portosystemischer Shunt (TIPSS)-Anlage
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Determination of the frequency of occurrence of cardiac decompensation
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Measurements of cardiac function in MRI and echocardiography, additional laboratory work
Patients in this arm will receive three additional cardiac magnetic resonance imaging (MRI) scans with acquisition of cardiac function parameters, T1 and T2 relaxation time measurements and a newly introduced 4D-Flow sequence to assess changes in aortic and pulmonary artery flow. These patients will also receive extended echocardiography with additional parameters to diagnose cirrhotic cardiomyopathy. We will also analyse specific blood parameters that are not yet part of the clinical standard.
Intervention: Blood samples (Diagnostic Test)
Measurements of cardiac function in MRI and echocardiography, additional laboratory work
Patients in this arm will receive three additional cardiac magnetic resonance imaging (MRI) scans with acquisition of cardiac function parameters, T1 and T2 relaxation time measurements and a newly introduced 4D-Flow sequence to assess changes in aortic and pulmonary artery flow. These patients will also receive extended echocardiography with additional parameters to diagnose cirrhotic cardiomyopathy. We will also analyse specific blood parameters that are not yet part of the clinical standard.
Intervention: Cardiac MRI (Diagnostic Test)
Measurements of cardiac function in MRI and echocardiography, additional laboratory work
Patients in this arm will receive three additional cardiac magnetic resonance imaging (MRI) scans with acquisition of cardiac function parameters, T1 and T2 relaxation time measurements and a newly introduced 4D-Flow sequence to assess changes in aortic and pulmonary artery flow. These patients will also receive extended echocardiography with additional parameters to diagnose cirrhotic cardiomyopathy. We will also analyse specific blood parameters that are not yet part of the clinical standard.
Intervention: Echocardiography (Diagnostic Test)
Outcomes
Primary Outcomes
Determination of the frequency of occurrence of cardiac decompensation
Time Frame: From TIPSS to cardiac decompensation 12 Month
Cardiac decompensation is defined as one or a collection of the following new symptoms: Fatigue, Dyspnoea, Edema, jugular vein congestion, elevated pro-BNP, restricted heart function in echocardiography, clinically indicated chest x-ray with edema or pleura effusion. Clinical evaluation and diagnostic methods according to clinical standard are applied (e.g. x-ray and ultrasound if clinically needed).
Secondary Outcomes
- Acquisition of right and left heart function parameters in patients before TIPS implantation(1day before TIPS-Implantation)
- Acquisition of right and left heart function parameters in patients after TIPS implantation(1-3 days after TIPS-Implantation)
- Acquisition of right and left heart function parameters in patients 3 Month after TIPS implantation(about 3 month after TIPS-Implantation)
- Acquisition of T1 and T2 mapping without contrast agent administration during the course(1day before TIPS-Implantation to about 3 Month after)
- Evaluation of changes in flow parameters in the aorta and pulmonary artery(1day before TIPS-Implantation to about 3 Month after)
- Follow-up of echocardiographic parameters and correlation with cardiac MRI(1day before TIPS-Implantation to about 3 Month after)
- Correlation with laboratory markers (for inflammation, liver fibrosis, metabolism, cardiac remodeling)(1day before TIPS-Implantation to about 6 Month after)
Investigators
Stephanie Gräger
Radiologist
Jena University Hospital