Using 4D-flow MRI to assess liver blood flow in cirrhosis with portal hypertension
Tests 4D-flow MRI as a non-invasive way to measure portal hypertension in adults with cirrhosis.
Plain-language title generated from the registry record
Registry title: 4D-Flow MRI Assessment of Portal Hypertension and TIPS Outcomes in Cirrhosis
Key facts
- Where
- Paris, FranceSee the 2 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with cirrhosis: people with MASLD-related cirrhosis whose liver is still working well, and people with severe cirrhosis who are referred for a TIPS procedure.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Two groups: compensated cirrhosis from MASLD (a fatty liver disease linked to metabolic risk factors), or decompensated cirrhosis referred for TIPS (a shunt placed in the liver to lower pressure).
- Biomarker or test result
- For the MASLD group: liver stiffness above 15 kPa on transient elastography, or a liver biopsy showing fatty liver with stage 3 fibrosis or cirrhosis.
Main reasons for not taking part
- Cannot have an MRI (for example a pacemaker, defibrillator or cochlear implant)
- Had a liver transplant before
- Pregnant, breastfeeding, or able to become pregnant without effective contraception
- Under legal guardianship or unable to give consent
- MASLD group: other causes of liver disease, such as viral hepatitis, autoimmune liver disease or hemochromatosis
Read by machine on 13 November 2026.
Where in France
- Hopital Pitie-SalpetriereParis, FranceContact: Louis MEYBLUM, MDTaking people
- Service d'hépato-gastroentérologieParis, FranceContact: Marika RUDLER, ProfTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT07554183
- Record updated
- 13 October 2026
- Original description
PORTAL-4D is a prospective, interventional, non-randomized, parallel-group diagnostic study conducted at Pitié-Salpêtrière Hospital (Paris, France).Read full original descriptionShow less
Predicting Outcomes and Risk of Complications Related to Portal hyperTension by Non-invasive Assessment of Liver Flow With 4D MRI
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.
Inclusion: Applicable to both groups :; 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; Specific to the MASLD group :; 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 :; 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; Liver biopsy documenting steatosis with stage 3 fibrosis or cirrhosis; Alcohol consumption < 20 g/day for women and < 30 g/day for men, assessed using validated routine clinical questionnaires.
Exclusion: Prior liver transplantation; Participation in another interventional clinical study or currently within the exclusion period following a previous ongoing study; Specific to the TIPS group; Any contraindication to MRI (cardiac pacemaker, implantable cardioverter-defibrillator, cochlear implants, intraocular metallic foreign bodies, intracranial vascular clips); Other etiologies of chronic liver disease, including viral hepatitis, autoimmune liver disease, or hemochromatosis; Applicable to both groups :; Pregnancy, breastfeeding, or women of childbearing potential not using effective contraception; Individual under legal guardianship or trusteeship, or unable to provide informed consent; Patients undergoing salvage TIPS placement in the setting of hemorrhagic shock. Specific to the MASLD group.