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

NCT07554183 | Not Yet Recruiting

• 2 other identifiers: APHP2512082025-A01858-41
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

4D-Flow MRI; Hepatic Venous Pressure Gradient; Portal Hemodynamics; Noninvasive Liver Imaging; Hepatic Encephalopathy; Portal hypertension complications; TIPS; MASLD

Outcome Measures

Primary Outcomes (1)

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

  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

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

Secondary Outcomes (17)

• : Correlation between 4D Flow MRI measured flows and the percentage of shunt with the incidence of events related to portal hypertension

  6 months

• Correlation between proteomic signatures and the occurrence of hepatic encephalopathy

  Occurrence of hepatic encephalopathy will be monitored for 6 months following the TIPS procedure

• Correlation between transcriptomic signatures and the occurrence of hepatic encephalopathy

  Occurrence of hepatic encephalopathy will be monitored for 6 months following the TIPS procedure

• Correlation between metabolomic signatures and the occurrence of hepatic encephalopathy.

  Occurrence of hepatic encephalopathy will be monitored for 6 months following the TIPS procedure

• Correlation between viromic signatures and the occurrence of hepatic encephalopathy

  Occurrence of hepatic encephalopathy will be monitored for 6 months following the TIPS procedure

Study Arms (2)

TIPS group

EXPERIMENTAL

TIPS group : Adults with decompensated cirrhosis referred for transjugular intrahepatic portosystemic shunt (TIPS). Participants undergo 4D-flow liver MRI before and after TIPS placement, invasive pressure measurements, blood sampling, and 6-month follow-up to assess post-TIPS outcomes.

Other: 4D-Flow Liver and heart MRI with Gadolinium injection; Biological: Samples Without DNA

MASLD group

EXPERIMENTAL

MASLD group : Adults with compensated cirrhosis related to metabolic dysfunction-associated steatotic liver disease (MASLD). Participants undergo invasive HVPG measurement and 4D-flow liver MRI, with 6-month follow-up to assess portal hypertension-related complications and prognostic value of imaging parameters.

Other: 4D-Flow Liver and heart MRI with Gadolinium injection; Biological: Samples Without DNA

Interventions

4D-Flow Liver and heart MRI with Gadolinium injection OTHER

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.

MASLD group; TIPS group

Samples Without DNA BIOLOGICAL

Portal, hepatic and systemic veins blood collection

MASLD group; TIPS group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Applicable to both groups :
• Any contraindication to MRI (cardiac pacemaker, implantable cardioverter-defibrillator, cochlear implants, intraocular metallic foreign bodies, intracranial vascular clips).
• Prior liver transplantation.
• Pregnancy, breastfeeding, or women of childbearing potential not using effective contraception.
• Individual under legal guardianship or trusteeship, or unable to provide informed consent.
• Specific to the TIPS group
• Patients undergoing salvage TIPS placement in the setting of hemorrhagic shock. Specific to the MASLD group
• Other etiologies of chronic liver disease, including viral hepatitis, autoimmune liver disease, or hemochromatosis

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Sorbonne University: collaborator
• Institute of Cardiometabolism and Nutrition, France: collaborator

Study Sites (1)

Hôpital Pitié Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Fibrosis; Hypertension, Portal; Hepatic Encephalopathy

Interventions

Gadolinium; DNA

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Metals; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Louis MEYBLUM, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louis MEYBLUM, MD

CONTACT

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

Charles ROUX, MD

CONTACT

+33 1 42 16 27 70; charles.roux@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: April 28, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication.Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

FR (1)