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NCT Number: NCT06814990

Acquisition of Cardiac Function Parameters in MRI and Echocardiography in Patients with Ethyltoxic Liver Cirrhosis and Transjugular Intrahepatic Portosystemic Shunt (TIPSS) Placement

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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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jena University Hospital

Jena, Thuringia, 07747, Germany

Location status: Recruiting

Location contact

Stephanie Gräger

CONTACT

[email protected]

+4936419324856

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. 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

  1. Acquisition of right and left heart function parameters in patients before TIPS implantation

    Time frame: 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.

  2. Acquisition of right and left heart function parameters in patients after TIPS implantation

    Time frame: 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.

  3. Acquisition of right and left heart function parameters in patients 3 Month after TIPS implantation

    Time frame: 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.

  4. Acquisition of T1 and T2 mapping without contrast agent administration during the course

    Time frame: 1day before TIPS-Implantation to about 3 Month after

    Detection of changes in T1 and T2-relaxation time in ms in MRI

  5. Evaluation of changes in flow parameters in the aorta and pulmonary artery

    Time frame: 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.

  6. Follow-up of echocardiographic parameters and correlation with cardiac MRI

    Time frame: 1day before TIPS-Implantation to about 3 Month after

    Observation of changes in cardiac function via echocardiography and subsequent comparison with cardiac MRI parameters

  7. Correlation with laboratory markers (for inflammation, liver fibrosis, metabolism, cardiac remodeling)

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Stephanie Gräger

CONTACT

[email protected]

+4936419324800

Sponsors and collaborators

Lead sponsor

Stephanie Gräger

Other

Collaborators

  • Jena University Hospital

Registry information

Official study title

Erfassung Kardialer Funktionsparameter in MRT Und Echokardiographie Bei Patienten Mit Ethyltoxischer Leberzirrhose Und Transjugulärer Intrahepatischer Portosystemischer Shunt (TIPSS)-Anlage

Acronym: EVALUATION

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 7, 2025
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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