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

Study acronym: PORTAL-4D
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 30 days later Nov 1, 2027 → Dec 1, 2027
See other at-risk trials from Assistance Publique - Hôpitaux de Paris

Record History

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  1. Recruitment opened Show 6 more changesShow less
    • Primary completion pushed from Nov 1, 2027 to Dec 1, 2027
    • Study sites: 1 to 2
    • Start date changed from estimate of Jun 1, 2026 to Aug 25, 2026
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 17 of 17 entries
    • Study description revised
  2. Re-verified, no change to tracked fieldsv2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT07554183
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: Sorbonne University, Institute of Cardiometabolism and Nutrition, France
Conditions
(from sponsor)		 Cirrhosis, Portal Hypertension
Related terms Fibrosis, Hepatic Encephalopathy, Hypertension, Portal
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov