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Clinical Trials in France / NCT07554183
Starting soon Not applicable

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

NCT07554183 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Not applicable
Started
2026-06-01
Last updated
2026-06-24

Condition(s) studied

CirrhosisPortal Hypertension

Investigational drug(s) / intervention(s)

4D-Flow Liver and heart MRI with Gadolinium injectionSamples Without DNA

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.

Samples Without DNA: Portal, hepatic and systemic veins blood collection

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Applicable to both groups : 1. Age ≥ 18 years 2. Eligible to undergo MRI examination 3. Prior clinical evaluation completed 4. Covered by a national health insurance scheme or beneficiary thereof (excluding State Medical Aid AME) 5. Patient informed and written informed consent obtained Specific to the MASLD group : 6. Indication for TIPS validated during a multidisciplinary team meeting and documented in the patient's medical record, including one of the following: * Refractory ascites * Hepatic hydrothorax * Failure of secondary prophylaxis of variceal gastrointestinal bleeding * Preemptive TIPS * Preoperative TIPS Specific to the MASLD group : 7. Past or current exposure to metabolic risk factors (overweight, obesity, type 2 diabetes mellitus, arterial hypertension, dyslipidemia) 8. Liver stiffness \> 15 kPa measured by transient elastography 9. Liver biopsy documenting steatosis with stage 3 fibrosis or cirrhosis 10. Alcohol consumption \< 20 g/day for women and \< 30 g/day for men, assessed using validated routine clinical questionnaires Exclusion Criteria: Applicable to both groups : 1. Any contraindication to MRI (cardiac pacemaker, implantable cardioverter-defibrillator, cochlear implants, intraocular metallic foreign bodies, intracranial vascular clips). 2. Prior liver transplantation. 3. Pregnancy, breastfeeding, or women of childbearing potential not using effective contraception. 4. Individual under legal guardianship or trusteeship, or unable to provide informed consent. 5. Participation in another interventional clinical study or currently within the exclusion period following a previous ongoing study. Specific to the TIPS group 6. Patients undergoing salvage TIPS placement in the setting of hemorrhagic shock. Specific to the MASLD group 7. Other etiologies of chronic liver disease, including viral hepatitis, autoimmune liver disease, or hemochromatosis

Primary outcome measure(s)

  • Correlation between invasive hepatic venous pressure gradient (HVPG) and quantitative hepatic 4D-flow MRI hemodynamic parameters — Baseline (4D-flow MRI performed within 3 days before or after invasive measurements)
    The primary outcome is the association between the invasive hepatic venous pressure gradient (HVPG; wedged hepatic venous pressure minus free hepatic venous pressure) measured during transjugular catheterization and quantitative hepatic 4D-flow MRI-derived parameters, including flow rate and peak velocity in the portal venous system (main portal vein and right/left branches), splenic vein, superior mesenteric vein, hepatic veins, and inferior vena cava. When available, direct portal pressure will be recorded as supportive invasive data

Trial sites (1)

FacilityCityRegionStatus
Hôpital Pitié Salpêtrière Paris France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07554183 on ClinicalTrials.gov ↗ ← All trials in France