Trials / Completed
CompletedNCT03443934
Hemodynamic Alterations in Liver Cirrhosis Validated by Non-invasive MR Compared to Invasive Assessment
Hemodynamic Alterations in Liver Cirrhosis Compared to Healthy Subjects: Assessment of Non-invasive MRI and Echocardiography Compared to Liver Vein Catheterization
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 89 (actual)
- Sponsor
- Hvidovre University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 82 Years
- Healthy volunteers
- Accepted
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
Conditions
Timeline
- Start date
- 2017-04-01
- Primary completion
- 2021-04-15
- Completion
- 2021-04-21
- First posted
- 2018-02-23
- Last updated
- 2021-08-10
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT03443934. Inclusion in this directory is not an endorsement.