Brief Summary

GRIPonMASH will assist (primary) health care providers clinicians to implement the latest patient care pathway, as described by the European Association for the Study of the Liver (EASL), to identify patients at risk of severe metabolic dysfunction-associated steatotic liver disease (MASLD) and to raise awareness. The primary objective is to implement a transmural patient care pathway, in order to identify patients with MASLD and its progressive form metabolic dysfunction-associated steatohepatitis (MASH) in primary care centres and clinics in 10 European countries.

Conditions

• MASH
• MASLD
• MASH With Fibrosis
• Fibrosis, Liver
• Steatosis of Liver
• Type 2 Diabetes
• Obesity
• Metabolic Syndrome
• Arterial Hypertension

Primary Outcome Measures

• Prevalence of liver steatosis and MASLD estimated by FibroScan CAP in patients at risk (Baseline)
  Steatosis grade deduced from controlled attenuation parameter (CAP) measurement with Fibroscan
• Prevalence of liver fibrosis estimated by FibroScan LSM in patients at risk (Baseline)
  Fibrosis stage deduced from liver stiffness measurement (LSM) by vibration controlled transient elastography (VCTE) measurement with Fibroscan
• Prevalence of at-risk MASH estimated by FAST score in patients at risk (Baseline)
  At-risk MASH deduced from FAST score
• *Subset of patients: prevalence of MASH in patients at risk (16 or 30 weeks)
  MASH diagnosis confirmed by histology (NAS/SAF criteria) upon liver biopsy; only in patients with \>12 kPa at 1st FibroScan or \>=8 kPa at 2nd FibroScan
• Comparison of the prevalence of MASLD, liver fibrosis and (at-risk) MASH between the participating countries (Baseline (1-3) to 16/30 weeks for biopsy-confirmed MASH (4))
  Prevalence (see outcome 1-4) stratified per country
• Evaluate added value of a 2-step pathway as compared to FibroScan only for detection of high-risk patients (Baseline)
  Number of patients at risk identified by FIB-4 compared to numbers found using LSM by VCTE with FibroScan measurements, and numbers found in combination

Countries

Belgium, Czechia, France, Germany, Greece, Italy, Netherlands, Portugal, Romania, Spain

Locations and Investigators

• Hôpital Erasme, Cliniques Universitaires De Bruxelles, Brussels, Belgium (Recruiting)
• Antwerp University Hospital, Antwerp, Belgium (Active not recruiting)
• 4th internal clinic General University Hospital, Prague, Czechia (Not yet recruiting)
• Hôpital de la Pitié Salpêtrière, Paris, France (Not yet recruiting)
• Universitätsmedizin Mainz, Mainz, Germany (Recruiting)
• Universitätsklinikum des Saarlandes, Homburg, Germany (Not yet recruiting)
• Harokopio University of Athens, Athens, Greece (Not yet recruiting)
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS (FPG), Università Cattolica del Sacro Cuore (UCSC), Rome, Italy (Not yet recruiting)
• Amsterdam UMC, Amsterdam, Netherlands (Recruiting)
• Franciscus Gasthuis & Vlietland, Rotterdam, Netherlands (Recruiting)
• ULSSM - Unidade Local de Saúde Santa Maria, E.P.E, Lisbon, Portugal (Recruiting)
• Sacele Municipal Hospital, Sacele, Romania (Not yet recruiting)
• Hospital Universitario Virgen del Rocío, Seville, Spain (Recruiting)

Study Officials

• Manuel Castro Cabezas, MD/PhD (Principal Investigator) — Sint Franciscus Gasthuis
• Diederick E. Grobbee, MD/PhD/FESC (Principal Investigator) — UMC Utrecht
• Oscar H. Franco, MD/PhD/FESC/FFPH (Study Chair) — UMC Utrecht