Hemodynamic Alterations in Liver Cirrhosis Validated by Non-invasive MR Compared to Invasive Assessment

Study Overview
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Brief Summary
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Liver cirrhosis is a chronic disease characterized by a progressive accumulation of fibrosis, loss of liver function and portal hypertension leading to several hemodynamic changes.The exact pathophysiological mechanisms causing the hyperdynamic alterations in cirrhosis are not fully elucidated. Aim: The aim of the study is to assess hemodynamic alterations in liver cirrhosis by non-invasive MRI and echocardiography compared to portal hypertension measured with liver vein catheterization (HVPG, hepatic vein pressure gradient). Furthermore, the aim is to explore hemodynamic differences between cirrhotic patients and healthy subjects. Study design and cohort: The study has a cross-sectional design and a cohort with 99 patients with liver cirrhosis - with and without complications and 27 healthy volunteers. The patients are recruited at the Gastrounit Hvidovre University Hospital. The day before the first visit patients are hospitalized and fasting overnight. At first visit liver vein catheterization (LVC) and echocardiography are performed. Second visit must be performed within 4 weeks after first visit. At the second visit patients are fasting minimum 6 hours before having MR-flow scanning, cardiac-MR and MR-Elastography (MR-E). The healthy volunteers are only offered MR-flow scanning, cardiac MR and MR-E as well as urine- and blood tests Follow-up for liver-related clinical outcome and mortality in medical records

Detailed Description
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MR elastography, cardiac scan, phase contrast MRI of blood flow compared to LVC

Official Title
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Hemodynamic Alterations in Liver Cirrhosis Compared to Healthy Subjects: Assessment of Non-invasive MRI and Echocardiography Compared to Liver Vein Catheterization

Conditions
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Cirrhosis, Portal Hypertension, Liver Diseases, Liver Cirrhoses

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with liver cirrhosis or portal hypertension Patient of more than 18 and less than 82 years of age Exclusion Criteria: Patients who are unable to give informed consent Patients with absolute contraindication for MRI Pregnant women Patient with severe hemodynamic comorbidity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 82 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI-flow (mL/min) in splanchnic arterial compared to clinical severity of cirrhosis and to portal hypertension measured as HVPG (mmHg) during liver vein catheterization | To compare the flow and cardiac parameters measured by MRI with disease progression and with HVPG (mmHg) measured during liver vein catheterization (LVC) | During MRI-scan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic alterations in patients with liver cirrhosis measured as flow (mL/min) in relevant vessels compared to flow in healthy subjects | To characterize flow in cirrhotic patients compared to healthy subjects | During MRI-scan | 
| Measurements of hemodynamic alterations compared with different severity of liver cirrhosis defined by Child Pugh and MELD score | To assess the relation between severity of cirrhosis with changes in flow and cardiac-MRI | During MRI-scan | 
| MR-elastography measurements (kPa) to characterize severity of cirrhosis categorized with Child Pugh, MELD and HVPG | To assess the relation between severity of cirrhosis and changes in liver and spleen stiffness | During MRI-scan | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodynamic assessments, Echocardiography, MR-Elastography, Liver vein catheterization, Liver Cirrhosis, Cirrhotic cardiomyopathy, Cirrhotic complications, Magnetic Resonance Imaging