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

H

Hvidovre University Hospital

Status

Completed

Conditions

Liver Cirrhoses
Portal Hypertension
Cirrhosis
Liver Diseases

Study type

Observational

Funder types

Other

Identifiers

NCT03443934
16048555

Details and patient eligibility

About

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

Full description

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

Enrollment

89 patients

Sex

All

Ages

18 to 82 years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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