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

NCT03443934 | Completed

• 1 other identifier: 16048555
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (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

  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 Outcomes (3)

• Hemodynamic alterations in patients with liver cirrhosis measured as flow (mL/min) in relevant vessels compared to flow in healthy subjects

  During MRI-scan

• Measurements of hemodynamic alterations compared with different severity of liver cirrhosis defined by Child Pugh and MELD score

  During MRI-scan

• MR-elastography measurements (kPa) to characterize severity of cirrhosis categorized with Child Pugh, MELD and HVPG

  During MRI-scan

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients with liver cirrhosis or portal hypertension Patient of more than 18 and less than 82 years of age

You may not qualify if:

• Patients who are unable to give informed consent Patients with absolute contraindication for MRI Pregnant women Patient with severe hemodynamic comorbidity

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

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

Hvidovre, 2650, Denmark

Location

Related Publications (2)

• Mynster Kronborg T, Webel H, O'Connell MB, Danielsen KV, Hobolth L, Moller S, Jensen RT, Bendtsen F, Hansen T, Rasmussen S, Juel HB, Kimer N. Markers of inflammation predict survival in newly diagnosed cirrhosis: a prospective registry study. Sci Rep. 2023 Nov 16;13(1):20039. doi: 10.1038/s41598-023-47384-2.

  PMID: 37973887 DERIVED

• 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.

  PMID: 35916685 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Hypertension, Portal; Liver Diseases; Fibrosis; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Flemming Bendtsen, Professor

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: February 10, 2018
• First Posted: February 23, 2018
• Study Start: April 1, 2017
• Primary Completion: April 15, 2021
• Study Completion: April 21, 2021
• Last Updated: August 10, 2021

Record last verified: 2021-08

Locations

DK (1)