Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis

Description

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.

Conditions

Nonalcoholic Steatohepatitis

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Study Overview

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Study Details

Study overview

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.

Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis

Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis

Condition
Nonalcoholic Steatohepatitis
Intervention / Treatment

-

Contacts and Locations

Rochester

Mayo Clinic in Rochester, Rochester, Minnesota, United States, 55905

Richmond

Virginia Commonwealth University, Richmond, Virginia, United States, 23298

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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)
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Virginia Commonwealth University,

Mohammad S Siddiqui, MD, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

2027-12