Erfassung Kardialer Funktionsparameter in MRT Und Echokardiographie Bei Patienten Mit Ethyltoxischer Leberzirrhose Und transjugulärer Intrahepatischer Portosystemischer Shunt (TIPSS)-Anlage
| Registry | NCT06814990, acronym EVALUATION |
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, diagnostic |
| Enrollment | 80 (Estimated) |
| Sponsor | Stephanie Gräger (Other); collaborators: Jena University Hospital |
| Conditions | MASLD, Liver Cirrhosis, Alcoholic, Cirrhosis of Liver, Heart Decompensation, TIPS |
| Interventions | Cardiac MRI, Blood samples, Echocardiography (Diagnostic test) |
| Dates | start 2024-04-19, primary completion 2027-04-19 (estimated), completion 2027-04-19 (estimated), first posted 2025-02-07, last updated 2026-08-04 |
| Locations | 1 site in Germany |
Related Papers Related Patents Related Grants Related Experts
All trials for MASLD All trials for Liver Cirrhosis, Alcoholic All trials of Cardiac MRI All trials of Blood samples
-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).
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Measurements of cardiac function in MRI and echocardiography, additional laboratory work | Experimental | Diagnostic Test: Cardiac MRI; Diagnostic Test: Blood samples; Diagnostic Test: Echocardiography | 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. |
- Cardiac MRI (Diagnostic test): Additional to standard clinical practice Patients will receive a cardiac magnetic resonance imaging without contrast. Measured parameters are enddoastolic and endsystolic volume (in ml oder ml/body surface area (BSA)), stroke volume (in ml) of right and left ventricle absolute and relatvie to body surface area (BSA), ejection fraction in % of right and left ventricle, myocardial Strain in % of right and left ventricle if applicable. T1 and T2 relaxation times are obtained and aortic and pulmonary artery flow parameters are measured.
- Blood samples (Diagnostic test): We will take additional blood samples for the analysis of markers of bacterial translocation (e.g. LBP, EndoCAb, 16S rRNA), detection of bacterial markers (bacterial extracellular vesicles), inflammatory markers (e.g. IL-1ß, TNF-α, TGF-ß, IL-6, CXCL8, IL1-RA, IL-10, IL-18) and monocyte/macrophage activation markers (sCD14, sCD163, sCD87, sCD206), bile acids (including TCA, GCA, GCDCA, TCDCA, TLCA, GLCA, TDCA, GDCA, CA, CDCA, UDCA, DCA, TUDCA, LCA), lipids and lipoproteins (triglyerides, cholesterol, LDL/HDL cholesterol), coagulation factors (e.g. VWF, ADAMTS13, fibrinogen), markers of cardiac remodeling (e.g. NT-proBNP; troponin, VEGF-D, cleaved Gasdermin D, HMGB1) and Immunophenotyping of monocytes/macrophages, T and B cells (e.g. CD14, CD16, MERTK, CD4, CD127, CD25, TREM1/2).
- Echocardiography (Diagnostic test): Patients will receive an extended echocardiographic protocol. In addition to standard clinical parameters, we will collect study specific parameters such as LV EF in %, global longitudinal strain in %, septal e' velocity (cm/s), E/e' ratio, left atrial volume index (LAVI) (in ml/m2), tricuspid regurgitation velocities (m/s).
+Outcome measures
Primary outcomes
- Determination of the frequency of occurrence of cardiac decompensation [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]: Monitoring changes in cardiac function using cardiac MRI. Measured parameters are end diastolic and end systolic volumes (in ml or ml/BSA), stroke volume (in ml) of the right and left ventricle absolute and relative to body surface area (BSA), ejection fraction in percent of the right and left ventricle, myocardial strain in percent of the right and left ventricle if applicable.
- Acquisition of right and left heart function parameters in patients after TIPS implantation [1-3 days after TIPS-Implantation]: Monitoring changes in cardiac function using cardiac MRI. Measured parameters are end diastolic and end systolic volumes (in ml or ml/BSA), stroke volume (in ml) of the right and left ventricle absolute and relative to body surface area (BSA), ejection fraction in percent of the right and left ventricle, myocardial strain in percent of the right and left ventricle if applicable.
- Acquisition of right and left heart function parameters in patients 3 Month after TIPS implantation [about 3 month after TIPS-Implantation]: Monitoring changes in cardiac function using cardiac MRI. Measured parameters are end diastolic and end systolic volumes (in ml or ml/BSA), stroke volume (in ml) of the right and left ventricle absolute and relative to body surface area (BSA), ejection fraction in percent of the right and left ventricle, myocardial strain in percent of the right and left ventricle if applicable.
- Acquisition of T1 and T2 mapping without contrast agent administration during the course [1day before TIPS-Implantation to about 3 Month after]: Detection of changes in T1 and T2-relaxation time in ms in MRI
- Evaluation of changes in flow parameters in the aorta and pulmonary artery [1day before TIPS-Implantation to about 3 Month after]: Using newly implemented 4D Flow in MRI to observe changes in arterial flow and improve clinical usability of the sequence.
- Follow-up of echocardiographic parameters and correlation with cardiac MRI [1day before TIPS-Implantation to about 3 Month after]: Observation of changes in cardiac function via echocardiography and subsequent comparison with cardiac MRI parameters
- Correlation with laboratory markers (for inflammation, liver fibrosis, metabolism, cardiac remodeling) [1day before TIPS-Implantation to about 6 Month after]: Correlation of clinical and imaging parameters with different blood markers which are aquired to clinical standard (Serum sodium, Quick, INR, pTT, Crea, urea, albumin, CRP, ALAT, ASAT, Bili, venous pH, LDH, lactate, glucose, complete blood count) and study specific (markers of bacterial translocation (e.g. LBP, EndoCAb, 16S rRNA), detection of bacterial markers (bacterial extracellular vesicles), inflammatory markers (e.g. IL-1ß, TNF-α, TGF-ß, IL-6, CXCL8, IL1-RA, IL-10, IL-18) and monocyte/macrophage activation markers (sCD14, sCD163, sCD87, sCD206), bile acids (including TCA, GCA, GCDCA, TCDCA, TLCA, GLCA, TDCA, GDCA, CA, CDCA, UDCA, DCA, TUDCA, LCA), lipids and lipoproteins (triglyerides, cholesterol, LDL/HDL cholesterol), coagulation factors (e.g. VWF, ADAMTS13, fibrinogen), markers of cardiac remodeling (e.g. NT-proBNP; troponin, VEGF-D, cleaved Gasdermin D, HMGB1) and Immunophenotyping of monocytes/macrophages, T and B cells (e.g. CD14, CD16, MERTK, CD4, CD127, CD25, TREM1/2).
+Eligibility
Sex: All, ages: 18 Years to 99 Years
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
+Locations (1)
| Facility | City | Country | Status |
|---|
| Jena University Hospital | Jena, Thuringia | Germany | Recruiting |
+Investigators
- Stephanie Gräger, Principal investigator, Jena University Hospital
- Stefanie Quickert, Principal investigator, Jena University Hospital
- René Aschenbach, Principal investigator, Jena University Hospital
- Alexander Zipprich, Principal investigator, Jena University Hospital