Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-20 @ 6:25 PM
Study NCT ID:
NCT03315767
Status:
UNKNOWN
Last Update Posted:
2017-10-20
First Post:
2017-10-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spleen-ARFI-assisted-Portal-Hypertension-Evaluation-Study (SAPHES)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006975', 'term': 'Hypertension, Portal'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-16', 'studyFirstSubmitDate': '2017-10-16', 'studyFirstSubmitQcDate': '2017-10-16', 'lastUpdatePostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in ARFI-elastography value for spleen due to beta-blocker therapy', 'timeFrame': '6 and 12 weeks', 'description': 'ARFI-elastography: measured in m/s'}], 'secondaryOutcomes': [{'measure': 'Correlation between changes in HVPG-values and ARFI-elastography values for liver', 'timeFrame': '6 and 12 weeks', 'description': 'HVPG-values: measured in mmHg; ARFI-elastography: measured in m/s'}, {'measure': 'Correlation between changes in HVPG-values and ARFI-elastography values for spleen', 'timeFrame': '6 and 12 weeks', 'description': 'HVPG-values: measured in mmHg; ARFI-elastography: measured in m/s'}, {'measure': 'Correlation between changes in HVPG-values and portal vein flow measurements', 'timeFrame': '6 and 12 weeks', 'description': 'HVPG-values: measured in mmHg; Portal vein flow: measured in cm/s'}, {'measure': 'Correlation between changes in grade of esophageal varices and HVPG-values', 'timeFrame': '12 weeks', 'description': 'esophageal varices: modified Poquet classification; HVPG-values: measured in mmHg'}, {'measure': 'Correlation between changes in grade of esophageal varices and ARFI-values for liver', 'timeFrame': '12 weeks', 'description': 'esophageal varices: modified Poquet classification; ARFI-elastography: measured in m/s'}, {'measure': 'Correlation between changes in grade of esophageal varices and ARFI-values for spleen', 'timeFrame': '12 weeks', 'description': 'esophageal varices: modified Poquet classification; ARFI-elastography: measured in m/s'}, {'measure': 'Correlation between changes in grade of esophageal varices and Portal vein flow', 'timeFrame': '12 weeks', 'description': 'Portal vein flow: measured in cm/s; esophageal varices: modified Poquet classification'}, {'measure': 'Change in ARFI-elastography value for liver due to beta-blocker therapy', 'timeFrame': '6 and 12 weeks', 'description': 'ARFI-elastography: measured in m/s'}, {'measure': 'Change in portal vein flow value due to beta-blocker therapy', 'timeFrame': '6 and 12 weeks', 'description': 'Portal vein flow: measured in cm/s'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HVPG', 'portal hypertension', 'ARFI', 'portal vein flow', 'advanced liver chronic disease (ACLD)'], 'conditions': ['Hypertension, Portal']}, 'referencesModule': {'references': [{'pmid': '36117519', 'type': 'DERIVED', 'citation': 'Binzberger A, Hanle M, Pfahler M, Kratzer W, Seufferlein T, Zizer E. Spleen and Liver Stiffness Evaluation by ARFI Imaging: A Reliable Tool for a Short-Term Monitoring of Portal Hypertension? Int J Hepatol. 2022 Sep 9;2022:7384144. doi: 10.1155/2022/7384144. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates correlation in changes of HVPG-pressure values and stiffness values (ARFI) for spleen and liver and flow-volume values in Portal vein in patients with liver cirrhosis/Portal Hypertension, respectively, after new-admission of beta-blocker therapy.', 'detailedDescription': 'Portal Hypertension is the most important risk factor for development of liver cirrhosis-linked complications (e.g. ascites, variceal bleeding, hepatocellular carcinoma, etc.). The invasive HVPG-technique is the standard-of-care Investigation for Evaluation of Portal Hypertension. Administration of Beta-Blocker-therapy results in dropping of the elevated Portal vein pressure values so Overall-survival rate and incidence of liver-cirrhosis-linked complications can be ameliorated. Ultrasound-based Investigation of liver and Spleen-stiffness and of portal-vein-flow-volume, respectively, are the non-invasive methods for Evaluation of Portal Hypertension. But the cut-off values for detection of significant Portal Hypertension by the ultrasound investigation strongly vary depending on the study performed. This study evaluates the changes in ARFI-assisted elastography measurements of liver and spleen and in portal vein flow values, respectively, compared with the recorded Delta in invasive hepatic vein pressure gradient (HVPG)-values for patients with portal hypertension and new administered beta-blocker-therapy. The aim of this study is to evaluate value drop in liver- and Spleen-stiffness and portal-vein-flow required in corelation to a significant drop in HVPG-pressure after new-administered beta-blocker therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* liver cirrhosis\n* portal hypertension\n* indication to beta-blocker-therapy\n\nExclusion Criteria:\n\n* contraindication to beta-blocker-therapy\n* HVPG-measurement not feasible\n* portal vein thrombosis\n* hematologic underlying disease as the source for enlarged/stiff spleen or liver'}, 'identificationModule': {'nctId': 'NCT03315767', 'acronym': 'SAPHES', 'briefTitle': 'Spleen-ARFI-assisted-Portal-Hypertension-Evaluation-Study (SAPHES)', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulm'}, 'officialTitle': 'Prospective Evaluation of Non-invasive ARFI-elastography of Liver and Spleen and Portal Flow Measurement in Comparison With Invasive HVPG (Hepatic Venous Pressure Gradient)-Measurement for Patients With Portal Hypertension.', 'orgStudyIdInfo': {'id': 'SAPHES'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'cirrhosis patients', 'description': 'ARFI-elastography and portal vein flow measurement: Liver and spleen of patients with a scheduled HVPG-investigation will be examined by an ARFI-elastography-investigation. Additionally the portal vein flow will be assessed.\n\nThis examination will be done at d0 before the start of beta-blocker-administration and repeated as monitoring for portal hypertension treated by beta-blocker after 6 and 12 weeks, respectively.\n\nHVPG-measurement: HVPG-values will be assessed at d0, after 6 and after 12 Weeks, respectively.', 'interventionNames': ['Diagnostic Test: ARFI-elastography and portal vein flow measurement', 'Diagnostic Test: HVPG-measurement']}], 'interventions': [{'name': 'ARFI-elastography and portal vein flow measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'Liver and spleen-elastography assessed by ARFI-technique and the portal vein flow value-assessment by ultrasound investigation.', 'armGroupLabels': ['cirrhosis patients']}, {'name': 'HVPG-measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'Evaluation of Portal Hypertension by HVPG-measurement', 'armGroupLabels': ['cirrhosis patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ulm', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Eugen Zizer, MD', 'role': 'CONTACT', 'email': 'eugen.zizer@uniklinik-ulm.de', 'phone': '0049-731-500-44751'}], 'facility': 'Universitätsklinikum Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'centralContacts': [{'name': 'Eugen Zizer, MD', 'role': 'CONTACT', 'email': 'eugen.zizer@uniklinik-ulm.de', 'phone': '0049-73150044751'}, {'name': 'Mark Hänle', 'role': 'CONTACT', 'email': 'mark.haenle@uniklinik-ulm.de', 'phone': '0049-7315000'}], 'overallOfficials': [{'name': 'Eugen Zizer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ulm'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulm', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department Internal Medicine I', 'investigatorFullName': 'Thomas Seufferlein', 'investigatorAffiliation': 'University of Ulm'}}}}