[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635553":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":60,"collaborators":62,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":24,"enrollmentInfo":77,"targetDuration":24,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":96,"whyStopped":24,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"TIPS group","EXPERIMENTAL","TIPS group : Adults with decompensated cirrhosis referred for transjugular intrahepatic portosystemic shunt (TIPS). Participants undergo 4D-flow liver MRI before and after TIPS placement, invasive pressure measurements, blood sampling, and 6-month follow-up to assess post-TIPS outcomes.",[13,14],"Other: 4D-Flow Liver and heart MRI with Gadolinium injection","Biological: Samples Without DNA",{"label":16,"type":10,"description":17,"interventionNames":18},"MASLD group","MASLD group : Adults with compensated cirrhosis related to metabolic dysfunction-associated steatotic liver disease (MASLD). Participants undergo invasive HVPG measurement and 4D-flow liver MRI, with 6-month follow-up to assess portal hypertension-related complications and prognostic value of imaging parameters.",[13,14],[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"4D-Flow Liver and heart MRI with Gadolinium injection","Non-invasive hepatic 4D-flow magnetic resonance imaging performed with gadolinium contrast to quantify portal and systemic venous blood flow, velocities, and shunt fraction. Measurements are compared with invasive hepatic venous pressure gradient (HVPG) values and clinical outcomes to assess diagnostic accuracy and prognostic value for portal hypertension-related complications.",[16,9],null,{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":24},"BIOLOGICAL","Samples Without DNA","Portal, hepatic and systemic veins blood collection",[16,9],[31],{"name":32,"affiliation":5,"role":33},"Louis MEYBLUM, MD","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":24,"email":38},"CONTACT","+331 84 82 82 68","louis.meyblum@aphp.fr",{"name":40,"role":36,"phone":41,"phoneExt":24,"email":42},"Charles ROUX, MD","+33 1 42 16 27 70","charles.roux@aphp.fr",[44],{"facility":45,"status":24,"city":46,"state":24,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Hôpital Pitié Salpêtrière","Paris","75013","France","FR",{"type":51,"coordinates":52},"Point",[53,54],2.3488,48.85341,{"lat":54,"lon":53},[57,59],{"name":32,"role":36,"phone":58,"phoneExt":24,"email":38},"01 84 82 82 68",{"name":40,"role":36,"phone":41,"phoneExt":24,"email":42},{"type":61,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[63,65],{"name":64,"class":6},"Sorbonne University",{"name":66,"class":6},"Institute of Cardiometabolism and Nutrition, France","100635553","4d-flow-mri-assessment-of-portal-hypertension-and-tips-outcomes-in-cirrhosis-100635553",false,"NCT07554183","4D-Flow MRI Assessment of Portal Hypertension and TIPS Outcomes in Cirrhosis","Predicting Outcomes and Risk of Complications Related to Portal hyperTension by Non-invasive Assessment of Liver Flow With 4D MRI","PORTAL-4D","Inclusion Criteria:\n\nApplicable to both groups :\n\n1. Age ≥ 18 years\n2. Eligible to undergo MRI examination\n3. Prior clinical evaluation completed\n4. Covered by a national health insurance scheme or beneficiary thereof (excluding State Medical Aid AME)\n5. Patient informed and written informed consent obtained\n\n   Specific to the MASLD group :\n6. Indication for TIPS validated during a multidisciplinary team meeting and documented in the patient's medical record, including one of the following:\n\n   * Refractory ascites\n   * Hepatic hydrothorax\n   * Failure of secondary prophylaxis of variceal gastrointestinal bleeding\n   * Preemptive TIPS\n   * Preoperative TIPS\n\n   Specific to the MASLD group :\n7. Past or current exposure to metabolic risk factors (overweight, obesity, type 2 diabetes mellitus, arterial hypertension, dyslipidemia)\n8. Liver stiffness \\> 15 kPa measured by transient elastography\n9. Liver biopsy documenting steatosis with stage 3 fibrosis or cirrhosis\n10. Alcohol consumption \\\u003C 20 g\u002Fday for women and \\\u003C 30 g\u002Fday for men, assessed using validated routine clinical questionnaires\n\nExclusion Criteria:\n\nApplicable to both groups :\n\n1. Any contraindication to MRI (cardiac pacemaker, implantable cardioverter-defibrillator, cochlear implants, intraocular metallic foreign bodies, intracranial vascular clips).\n2. Prior liver transplantation.\n3. Pregnancy, breastfeeding, or women of childbearing potential not using effective contraception.\n4. Individual under legal guardianship or trusteeship, or unable to provide informed consent.\n5. Participation in another interventional clinical study or currently within the exclusion period following a previous ongoing study.\n\n   Specific to the TIPS group\n6. Patients undergoing salvage TIPS placement in the setting of hemorrhagic shock. Specific to the MASLD group\n7. Other etiologies of chronic liver disease, including viral hepatitis, autoimmune liver disease, or hemochromatosis","ALL","18 Years",{"count":78,"type":79},60,"ESTIMATED","INTERVENTIONAL",[82],"NA","PORTAL-4D is a prospective, interventional, non-randomized, parallel-group diagnostic study conducted at Pitié-Salpêtrière Hospital (Paris, France).\n\nPortal hypertension is the main driver of hepatic decompensation and is associated with ascites, variceal bleeding, hepatic encephalopathy, and reduced survival. The current gold standard for assessing portal hypertension is the invasive hepatic venous pressure gradient (HVPG) measurement performed via the transjugular route. However, HVPG is invasive, operator-dependent, and limited to specialized centers. A reliable non-invasive alternative is therefore highly needed.\n\n60 adults patients with cirrhosis will be enrolled and divided into two parallel groups: MASLD group (n=24): Patients with compensated cirrhosis related to metabolic dysfunction-associated steatotic liver disease (MASLD).\n\nTIPS group (n=36): Patients with decompensated cirrhosis referred for transjugular intrahepatic portosystemic shunt (TIPS) placement.\n\nThe primary objective is to assess the correlation between invasive HVPG values and 4D-flow MRI parameters. Secondary objectives include evaluating the prognostic value of 4D-flow MRI in predicting portal hypertension-related complications and post-TIPS outcomes within 6 months.\n\nThe study is expected to validate 4D-flow MRI as an non-invasive diagnostic and prognostic tool for portal hypertension, potentially improving patient selection for TIPS and reducing reliance on invasive procedures.",[85,86],"Cirrhosis","Portal Hypertension",[88,89,90,91,92,93,94,95],"4D-Flow MRI","Hepatic Venous Pressure Gradient","Portal Hemodynamics","Noninvasive Liver Imaging","Hepatic Encephalopathy","Portal hypertension complications","TIPS","MASLD","NOT_YET_RECRUITING","2026-06-22",{"date":99,"type":100},"2026-06-24","ACTUAL",{"date":102,"type":79},"2026-06-01",{"date":104,"type":79},"2028-05-01",{"name":5,"class":6},1]