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

NCT07554183 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-28

No results posted yet for this study

Summary

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.

Conditions

  • Cirrhosis
  • Portal Hypertension

Interventions

OTHER

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.

BIOLOGICAL

Samples Without DNA

Portal, hepatic and systemic veins blood collection

Sponsors & Collaborators

  • Sorbonne University

    collaborator OTHER

  • Institute of Cardiometabolism and Nutrition, France

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Louis MEYBLUM, MD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-11-01
Completion
2028-05-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07554183 on ClinicalTrials.gov