Clinical trial NCT03443934: Hemodynamic Alterations in Liver Cirrhosis Validated by Non-invasive MR Compared to Invasive Assessment
Official title: Hemodynamic Alterations in Liver Cirrhosis Compared to Healthy Subjects: Assessment of Non-invasive MRI and Echocardiography Compared to Liver Vein Catheterization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Portal Hypertension
Liver Diseases
Liver Cirrhoses
Cirrhosis
Keywords: Hemodynamic assessments
Echocardiography
MR-Elastography
Liver vein catheterization
Liver Cirrhosis
Cirrhotic cardiomyopathy
Cirrhotic complications
Magnetic Resonance Imaging
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: During MRI-scan
Secondary outcomes:
measure: Hemodynamic alterations in patients with liver cirrhosis measured as flow (mL/min) in relevant vessels compared to flow in healthy subjects
timeFrame: During MRI-scan
measure: Measurements of hemodynamic alterations compared with different severity of liver cirrhosis defined by Child Pugh and MELD score
timeFrame: During MRI-scan
measure: MR-elastography measurements (kPa) to characterize severity of cirrhosis categorized with Child Pugh, MELD and HVPG
timeFrame: During MRI-scan
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Centre of Gastroenterology, Dept. of medicine. Hvidovre University Hospital
Study officials:
affiliation: Professor
name: Flemming Bendtsen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Danielsen KV, Wiese S, Busk T, Nabilou P, Kronborg TM, Petersen CL, Hove JD, Moller S, Bendtsen F. Cardiovascular Mapping in Cirrhosis From the Compensated Stage to Hepatorenal Syndrome: A Magnetic Resonance Study. Am J Gastroenterol. 2022 Aug 1;117(8):1269-1278. doi: 10.14309/ajg.0000000000001847. Epub 2022 Jun 3.