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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03443934
• Other study ID #: 16048555
• Status: Completed
• Start date: April 1, 2017
• Est. completion date: April 21, 2021

Study information

• Verified date: August 2021
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: April 21, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 82 Years

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Hypertension, Portal
• Liver Cirrhoses
• Liver Cirrhosis
• Liver Diseases
• Portal Hypertension

Locations

Country	Name	City	State
Denmark	Centre of Gastroenterology, Dept. of medicine. Hvidovre University Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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