Hemodynamic Alterations in Liver Cirrhosis Validated by Non-invasive MR Compared to Invasive Assessment
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|ClinicalTrials.gov Identifier: NCT03443934|
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : August 7, 2019
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.
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 54 patients with liver cirrhosis - with and without complications and 18 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
|Condition or disease|
|Portal Hypertension Liver Diseases Liver Cirrhoses Cirrhosis|
|Study Type :||Observational|
|Estimated Enrollment :||54 participants|
|Official Title:||Hemodynamic Alterations in Liver Cirrhosis Compared to Healthy Subjects: Assessment of Non-invasive MRI and Echocardiography Compared to Liver Vein Catheterization|
|Actual Study Start Date :||April 1, 2017|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||April 2023|
- MRI-flow (mL/min) in splanchnic arterial compared to portal hypertension measured as HVPG (mmHg) during liver vein catheterization [ Time Frame: During MRI-scan ]To compare the flow measured by MRI with findings in echocardiography and HVPG (mmHg) measured during liver vein catheterization (LVC)
- Hemodynamic alterations in patients with liver cirrhosis measured as flow (mL/min) in relevant vessels compared to flow in healthy subjects [ Time Frame: During MRI-scan ]To characterize flow in cirrhotic patients compared to healthy subjects
- Measurements of hemodynamic alterations compared with different severity of liver cirrhosis defined by Child Pugh and MELD score [ Time Frame: During MRI-scan ]To assess the relation between severity of cirrhosis with changes in flow and cardiac-MRI
- MR-elastography measurements (kPa) to characterize severity of cirrhosis categorized with Child Pugh, MELD and HVPG [ Time Frame: During MRI-scan ]To assess the relation between severity of cirrhosis and changes in liver and spleen stiffness
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443934
|Contact: Karen Danielsen||+45 firstname.lastname@example.org|
|Contact: Flemming Bendtsen, Professoremail@example.com|
|Centre of Gastroenterology, Dept. of medicine. Hvidovre University Hospital||Recruiting|
|Hvidovre, Denmark, 2650|
|Contact: Flemming Bendtsen, Professor firstname.lastname@example.org|
|Principal Investigator:||Flemming Bendtsen, Professor||Professor|