Erfassung Kardialer Funktionsparameter in MRT Und Echokardiographie Bei Patienten Mit Ethyltoxischer Leberzirrhose Und transjugulärer Intrahepatischer Portosystemischer Shunt (TIPSS)-Anlage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Determination of the frequency of occurrence of cardiac decompensation
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: 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.
干预措施: 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.
干预措施: Echocardiography (Diagnostic Test)
结局指标
主要结局
Determination of the frequency of occurrence of cardiac decompensation
时间窗: 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).
次要结局
- 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)
研究者
Stephanie Gräger
Radiologist
Jena University Hospital