Not Yet RecruitingNot Applicable

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

France60 participantsStarted 2026-06-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 18 years
✓. Eligible to undergo MRI examination
✓. Prior clinical evaluation completed
✓. Covered by a national health insurance scheme or beneficiary thereof (excluding State Medical Aid AME)
✓. Patient informed and written informed consent obtained
✓. Indication for TIPS validated during a multidisciplinary team meeting and documented in the patient's medical record, including one of the following:
✓. Past or current exposure to metabolic risk factors (overweight, obesity, type 2 diabetes mellitus, arterial hypertension, dyslipidemia)
✓. Liver stiffness \> 15 kPa measured by transient elastography

Exclusion criteria

✕. Any contraindication to MRI (cardiac pacemaker, implantable cardioverter-defibrillator, cochlear implants, intraocular metallic foreign bodies, intracranial vascular clips).

What they're measuring

Correlation between invasive hepatic venous pressure gradient (HVPG) and quantitative hepatic 4D-flow MRI hemodynamic parameters

Timeframe: Baseline (4D-flow MRI performed within 3 days before or after invasive measurements)

Trial details

NCT IDNCT07554183

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-11-01

Contact for this trial

Louis MEYBLUM, MD

+331 84 82 82 68 louis.meyblum@aphp.fr

View on ClinicalTrials.gov More Cirrhosis trials