An observational study in Portal Hypertension, Liver Diseases and Liver Cirrhoses, sponsored by Hvidovre University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 82 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-10.
Sponsored by Hvidovre University Hospital · Observational
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
MR elastography, cardiac scan, phase contrast MRI of blood flow compared to LVC
375 studies on the registry are indexed under Hypertension, Portal; 114 are open to participants now.
This study's enrollment of 89 is below the median of 150 across 135 observational studies indexed under Hypertension, Portal.
Browse Hypertension, Portal studies →Hvidovre University Hospital is the lead sponsor of 299 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
A cohort with 99 cirrhotic patients with and without complications and 27 healthy volunteers. The patients are recruited at the Gastrounit Hvidovre University Hospital
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 Patients with absolute for MRI Pregnant women Patient with severe hemodynamic comorbidity
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Time frame: During MRI-scan
Hemodynamic alterations in patients with liver cirrhosis measured as flow (mL/min) in relevant vessels compared to flow in healthy subjects
To characterize flow in cirrhotic patients compared to healthy subjects
Time frame: During MRI-scan
Measurements of hemodynamic alterations compared with different severity of liver cirrhosis defined by Child Pugh and MELD score
To assess the relation between severity of cirrhosis with changes in flow and cardiac-MRI
Time frame: During MRI-scan
MR-elastography measurements (kPa) to characterize severity of cirrhosis categorized with Child Pugh, MELD and HVPG
To assess the relation between severity of cirrhosis and changes in liver and spleen stiffness
Time frame: During MRI-scan
Plan to share: Undecided
Ran from Apr 2017 to primary completion in Apr 2021, 48 months.
Of 61 non-industry observational studies under Hypertension, Portal, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 256. This study's 48 months is above that.
Counting every sponsor, half of 65 studies reached it within 42 months; a quarter within 30 and three quarters within 256.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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