RecruitingNCT05720663

Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis

Sponsor

Virginia Commonwealth University

Enrollment

240 participants

Start Date

Apr 19, 2023

Study Type

OBSERVATIONAL

Conditions

Nonalcoholic Steatohepatitis

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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)