Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis

Recruiting now

Conditions studied: Nonalcoholic Steatohepatitis

In brief

Nonalcoholic Steatohepatitis (NASH) is a condition with increased amount of fat, inflammation and scarring in the liver. In compensated cirrhosis, the liver is coping with this damage and maintaining its important functions. Decompensation occurs when the liver becomes unable to perform all of its functions adequately. Variceal hemorrhage (bleeding from abnormal vessels in the liver called varices), Ascites (abnormal build-up of fluid in the abdomen), and Encephalopathy (brain confusion as a result of the liver not being able to get rid of toxic substances) are three symptoms of liver decompensation. The purpose of this research study is to investigate better ways to routinely monitor the condition of patients with NASH with compensated cirrhosis and to better pinpoint the development of decompensation in the livers of these patients.

Key facts

Study ID

NCT05720663

Run by

Virginia Commonwealth University

People needed

240

Starts

2023-04-19

Expected to finish

2027-12-01

Last updated by the study team

2026-04-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients with presence of NAFLD associated cirrhosis.
• Cirrhosis: biopsy confirmed or Agile F (F4) score > 0.45
• NAFLD as an etiology of liver disease will be determined based on presence of any of the following:
• Biopsy showing >5% steatosis or
• CAP > 280 dB/m or MR-PDFF>5%
• If CAP < 280 dB/m or MR-PDFF <5%, then must have type 2 diabetes and or 2 or more features of metabolic syndrome for 5 years (cryptogenic cirrhosis)

You may not qualify if…

• Refusal to consent
• Alcohol use > 14/21 gm/week cutoff
• Other causes of chronic liver disease
• MELD > 12
• Hepatic and extrahepatic cancers expected to limit life expectancy < 2 yrs
• prior hepatic resections, TIPS, splenic embolization
• prior decompensation events
• inability to fit into MRI (failed hula-hoop test)
• general contraindication for MRI contrast (GFR < 30 ml/min)
• contraindications for MRI
• pregnancy
• acute kidney injury
• reduced kidney function (GFR <30ml/min)

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States (enrolling)
• Virginia Commonwealth University — Richmond, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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