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

Completed

• Conditions: Portal Hypertension; Liver Diseases; Liver Cirrhoses; Cirrhosis

• Registration Number: NCT03443934
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

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

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

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2018-02-10
• Study First Submitted QC: 2018-02-18
• Study First Posted: 2018-02-23
• Primary Completion: 2021-04-15
• Study Completion: 2021-04-21
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-09
• Last Update Posted: 2021-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	During MRI-scan	To compare the flow and cardiac parameters measured by MRI with disease progression and with HVPG (mmHg) measured during liver vein catheterization (LVC)

Secondary Outcome Measures

Name	Time	Method
Hemodynamic alterations in patients with liver cirrhosis measured as flow (mL/min) in relevant vessels compared to flow in healthy subjects	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	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	During MRI-scan	To assess the relation between severity of cirrhosis and changes in liver and spleen stiffness

Trial Locations

Locations (1)

Centre of Gastroenterology, Dept. of medicine. Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark