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

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ClinicalTrials.gov Identifier: NCT03443934
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Flemming Bendtsen, 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 54 patients with liver cirrhosis - with and without complications and 18 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


Condition or disease
Portal Hypertension Liver Diseases Liver Cirrhoses Cirrhosis

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Study Type : Observational
Estimated Enrollment : 54 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
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis




Primary Outcome Measures :
  1. MRI-flow (mL/min) in splanchnic arterial compared to portal hypertension measured as HVPG (mmHg) during liver vein catheterization [ Time Frame: During MRI-scan ]
    To compare the flow measured by MRI with findings in echocardiography and 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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
A cohort with 54 cirrhotic patients with and without complications and 18 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 78 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443934


Contacts
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Contact: Karen Danielsen +45 22439449 karen.vagner.danielsen.02@regionh.dk
Contact: Flemming Bendtsen, Professor flemming.bendtsen@regionh.dk

Locations
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Denmark
Centre of Gastroenterology, Dept. of medicine. Hvidovre University Hospital Recruiting
Hvidovre, Denmark, 2650
Contact: Flemming Bendtsen, Professor       flemming.bendtsen@regionh.dk   
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
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Principal Investigator: Flemming Bendtsen, Professor Professor

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Responsible Party: Flemming Bendtsen, Professor, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT03443934     History of Changes
Other Study ID Numbers: 16048555
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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