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

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT07554183
Status
Not Yet Recruiting

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Conditions

  • Cirrhosis
  • Portal Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 4D-Flow Liver and heart MRI with Gadolinium injection — OTHER
    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.
  • Samples Without DNA — BIOLOGICAL
    Portal, hepatic and systemic veins blood collection

Study Details

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.

Key Dates

First listed
Apr 28, 2026
Start date
Jun 1, 2026
Status verified
Jun 2026
Primary completion
Nov 1, 2027
Completion
May 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: TIPS group
    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.
  • Experimental: 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.

Primary Outcome Measure

Correlation between invasive hepatic venous pressure gradient (HVPG) and quantitative hepatic 4D-flow MRI hemodynamic parameters [ Time Frame: Baseline (4D-flow MRI performed within 3 days before or after invasive measurements) ]

Central Contacts

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