Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-05 @ 8:51 PM
Study NCT ID:
NCT03443934
Status:
COMPLETED
Last Update Posted:
2021-08-10
First Post:
2018-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemodynamic Alterations in Liver Cirrhosis Validated by Non-invasive MR Compared to Invasive Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006975', 'term': 'Hypertension, Portal'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Standard clinical blood tests and pertinent bioactive substances is measured in blood and urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-09', 'studyFirstSubmitDate': '2018-02-10', 'studyFirstSubmitQcDate': '2018-02-18', 'lastUpdatePostDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': 'During MRI-scan', 'description': 'To compare the flow and cardiac parameters measured by MRI with disease progression and with HVPG (mmHg) measured during liver vein catheterization (LVC)'}], 'secondaryOutcomes': [{'measure': 'Hemodynamic alterations in patients with liver cirrhosis measured as flow (mL/min) in relevant vessels compared to flow in healthy subjects', 'timeFrame': 'During MRI-scan', 'description': 'To characterize flow in cirrhotic patients compared to healthy subjects'}, {'measure': 'Measurements of hemodynamic alterations compared with different severity of liver cirrhosis defined by Child Pugh and MELD score', 'timeFrame': 'During MRI-scan', 'description': 'To assess the relation between severity of cirrhosis with changes in flow and cardiac-MRI'}, {'measure': 'MR-elastography measurements (kPa) to characterize severity of cirrhosis categorized with Child Pugh, MELD and HVPG', 'timeFrame': 'During MRI-scan', 'description': 'To assess the relation between severity of cirrhosis and changes in liver and spleen stiffness'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemodynamic assessments', 'Echocardiography', 'MR-Elastography', 'Liver vein catheterization', 'Liver Cirrhosis', 'Cirrhotic cardiomyopathy', 'Cirrhotic complications', 'Magnetic Resonance Imaging'], 'conditions': ['Portal Hypertension', 'Liver Diseases', 'Liver Cirrhoses', 'Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '37973887', 'type': 'DERIVED', 'citation': "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."}, {'pmid': '35916685', 'type': 'DERIVED', 'citation': 'Danielsen 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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nAim:\n\nThe 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.\n\nStudy design and cohort:\n\nThe 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.\n\nThe 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).\n\nThe healthy volunteers are only offered MR-flow scanning, cardiac MR and MR-E as well as urine- and blood tests\n\nFollow-up for liver-related clinical outcome and mortality in medical records', 'detailedDescription': 'MR elastography, cardiac scan, phase contrast MRI of blood flow compared to LVC'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '82 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A cohort with 99 cirrhotic patients with and without complications and 27 healthy volunteers. The patients are recruited at the Gastrounit Hvidovre University Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with liver cirrhosis or portal hypertension Patient of more than 18 and less than 82 years of age\n\nExclusion Criteria:\n\nPatients who are unable to give informed consent Patients with absolute contraindication for MRI Pregnant women Patient with severe hemodynamic comorbidity'}, 'identificationModule': {'nctId': 'NCT03443934', 'briefTitle': 'Hemodynamic Alterations in Liver Cirrhosis Validated by Non-invasive MR Compared to Invasive Assessment', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Hemodynamic Alterations in Liver Cirrhosis Compared to Healthy Subjects: Assessment of Non-invasive MRI and Echocardiography Compared to Liver Vein Catheterization', 'orgStudyIdInfo': {'id': '16048555'}}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Centre of Gastroenterology, Dept. of medicine. Hvidovre University Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'overallOfficials': [{'name': 'Flemming Bendtsen, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD', 'investigatorFullName': 'Flemming Bendtsen', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}