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

August 9, 2021 updated by: Flemming Bendtsen, Hvidovre University Hospital

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

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

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

89

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Centre of Gastroenterology, Dept. of medicine. Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 82 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

A cohort with 99 cirrhotic patients with and without complications and 27 healthy volunteers. The patients are recruited at the Gastrounit Hvidovre University Hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

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
Time Frame: 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)
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
Time Frame: During MRI-scan
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
Time Frame: During MRI-scan
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
Time Frame: During MRI-scan
To assess the relation between severity of cirrhosis and changes in liver and spleen stiffness
During MRI-scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2017

Primary Completion (ACTUAL)

April 15, 2021

Study Completion (ACTUAL)

April 21, 2021

Study Registration Dates

First Submitted

February 10, 2018

First Submitted That Met QC Criteria

February 18, 2018

First Posted (ACTUAL)

February 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 10, 2021

Last Update Submitted That Met QC Criteria

August 9, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16048555

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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