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

NCT03443934 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 89

Last updated 2021-08-10

No results posted yet for this study

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

Sponsors & Collaborators

  • Hvidovre University Hospital

    lead OTHER

Principal Investigators

  • Flemming Bendtsen, Professor · Professor

Eligibility

Min Age
18 Years
Max Age
82 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2021-04-15
Completion
2021-04-21

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03443934 on ClinicalTrials.gov