NCT07554183Recruiting
4D-Flow MRI Assessment of Portal Hypertension and TIPS Outcomes in Cirrhosis
Predicting Outcomes and Risk of Complications Related to Portal hyperTension by Non-invasive Assessment of Liver Flow With 4D MRI
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 18 Mar 2026
- Start date
- 25 Aug 2026
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- High blood pressure
- NCT number
- NCT07554183
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 25 Aug 2026 to the primary completion date, 1 Dec 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service d'hépato-gastroentérologie Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hopital Pitie-Salpetriere Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.