4D-Flow MRI Assessment of Portal Hypertension and TIPS Outcomes in Cirrhosis

PORTAL-4D is a prospective, interventional, non-randomized, parallel-group diagnostic study conducted at Pitié-Salpêtrière Hospital (Paris, France). Portal 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. 60 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). TIPS group (n=36): Patients with decompensated cirrhosis referred for transjugular intrahepatic portosystemic shunt (TIPS) placement. The 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. The 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.

NCT Number	NCT07554183
Lead Sponsor	Assistance Publique - Hôpitaux de Paris Collaborators: Sorbonne University, Institute of Cardiometabolism and Nutrition, France
Conditions	Cirrhosis, Portal Hypertension
Enrollment	60 participants
Start Date	2026-06-01
Primary Completion	2027-11-01 (estimated)
Study Completion	2028-05-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-24