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

• ClinicalTrials.gov Identifier: NCT03443934
• Recruitment Status: Completed
• First Posted: February 23, 2018
• Last Update Posted: August 10, 2021
• Sponsor: Hvidovre University Hospital
• Information provided by (Responsible Party): Flemming Bendtsen, Hvidovre University Hospital

Study Description

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

Condition or disease
Portal Hypertension; Liver Diseases; Liver Cirrhoses; Cirrhosis

Detailed Description:

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

Study Design

• Study Type: Observational
• Actual Enrollment: 89 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Primary Completion Date: April 15, 2021
• Actual Study Completion Date: April 21, 2021

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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)

Secondary Outcome Measures :

1. 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
2. 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
3. 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

Standard clinical blood tests and pertinent bioactive substances is measured in blood and urine

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 82 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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

Criteria

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

Contacts and Locations

Locations

Denmark

Centre of Gastroenterology, Dept. of medicine. Hvidovre University Hospital

Hvidovre, Denmark, 2650

Sponsors and Collaborators

Hvidovre University Hospital

Investigators

• Principal Investigator: Flemming Bendtsen, Professor; Professor

More Information

• Responsible Party: Flemming Bendtsen, Professor, MD, Hvidovre University Hospital
• ClinicalTrials.gov Identifier: NCT03443934
• Other Study ID Numbers: 16048555
• First Posted: February 23, 2018
• Last Update Posted: August 10, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Flemming Bendtsen, Hvidovre University Hospital:

Hemodynamic assessments; Echocardiography; MR-Elastography; Liver vein catheterization; Liver Cirrhosis; Cirrhotic cardiomyopathy; Cirrhotic complications; Magnetic Resonance Imaging

Additional relevant MeSH terms:

Liver Cirrhosis; Liver Diseases; Hypertension, Portal; Fibrosis; Pathologic Processes; Digestive System Diseases