Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis

Virginia Commonwealth University (VCU)

Status

Enrolling

Conditions

Nonalcoholic Steatohepatitis

Treatments

Other: Standard of care

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT05720663

HM20024296

1R01DK129564 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

This clinical research study is done to investigate better ways to routinely monitor the condition of patients with Nonalcoholic Steatohepatitis (NASH) with compensated cirrhosis. The purpose of this study is to better pinpoint the development of decompensation in the livers of these patients (some symptoms are variceal hemorrhage, ascites, and encephalopathy, defined below).

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.

Aside from current routine procedures including blood draws, this study will check to see how effectively adding three additional procedures will help predict development of liver decompensation. These additional procedures are Spleen Stiffness Measurement (SSM) during a special liver ultrasound called a Fibroscan, an imagining scan called Magnetic Resonance Imagining (MRI) using a contrast agent called Gadoxetate Sodium to highlight cirrhosis, and an MRI scan called metabophenotype, which examines muscle composition of the liver.

Enrollment

240 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria