Portal HypertensionNCT03443934
Hemodynamic Alterations in Liver Cirrhosis Validated by Non-invasive MR Compared to Invasive Assessment
An observational study of Portal Hypertension and Liver Diseases, run by Hvidovre University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 82 yearsHealthy volunteers can take part
- Conditions the study is for
- Portal Hypertension, Liver Diseases, Liver Cirrhoses
- How many people
- 89 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2017to 21 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 82 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Patients with liver cirrhosis or portal hypertension Patient of more than 18 and less than 82 years of age
Who cannot join
- Patients who are unable to give informed consent Patients with absolute contraindication for MRI Pregnant women Patient with severe hemodynamic comorbidity
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Centre of Gastroenterology, Dept. of medicine. Hvidovre University Hospital
Hvidovre, 2650
About this study
Official title: Hemodynamic Alterations in Liver Cirrhosis Compared to Healthy Subjects: Assessment of Non-invasive MRI and Echocardiography Compared to Liver Vein Catheterization
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:
Read more
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
Read the detailed description
MR elastography, cardiac scan, phase contrast MRI of blood flow compared to LVC
- 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
- Medical subject headings
- Hypertension, Portal, Liver Diseases, Fibrosis, Liver Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
To characterize flow in cirrhotic patients compared to healthy subjects
Measured: 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
Measured: 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
Measured: During MRI-scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start1 Apr 2017
- Primary completion15 Apr 2021
- Study completion21 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flemming Bendtsen, Hvidovre University Hospital
- Investigators
- Flemming Bendtsen, Professor, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443934
- Sponsor's protocol ID
- 16048555
- Status last verified
- Aug 2021
- First submitted
- 10 Feb 2018
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37973887Danielsen 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.
PubMed 35916685
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Alterations in Liver Cirrhosis Compared to Healthy Subjects: Assessment of Non-invasive MRI and Echocardiography Compared to Liver Vein Catheterization
- ClinicalTrials.gov ID
- NCT03443934
- Acronym / sponsor ID
- 16048555
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 21 Apr 2021 (actual)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients with liver cirrhosis or portal hypertension Patient of more than 18 and less than 82 years of age
Key exclusion criteria (1 listed)
- Patients who are unable to give informed consent Patients with absolute contraindication for MRI Pregnant women Patient with severe hemodynamic comorbidity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: During MRI-scan
To compare the flow and cardiac parameters measured by MRI with disease progression and with HVPG (mmHg) measured during liver vein catheterization (LVC)
3 secondary outcomes
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
Measurements of hemodynamic alterations compared with different severity of liver cirrhosis defined by Child Pugh and MELD score
Time frame: During MRI-scan
MR-elastography measurements (kPa) to characterize severity of cirrhosis categorized with Child Pugh, MELD and HVPG
Time frame: During MRI-scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Derived from this study: PubMed 37973887Mynster 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.
- Derived from this study: PubMed 35916685Danielsen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flemming Bendtsen, Professor principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Portal Hypertension and Liver Diseases, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: During MRI-scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03443934, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.