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Recruiting NCT05720663

Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis

— Observational Nonalcoholic Steatohepatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard of care.
Who it may be relevant to
Registry conditions: Nonalcoholic Steatohepatitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Detailed 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.

Interventions

  • Other Standard of care
    Participants will receive the standard of care for their condition

Primary outcome measures

  • Number of deaths [Time frame: Up to 2 years]
  • Incidents of variceal hemorrhage [Time frame: Up to 2 years]
  • Incidents of ascites [Time frame: Up to 2 years]
  • Hepatic Encephalopathy (HE) [Time frame: Up to 2 years]
Secondary outcome measures (2)
  • Model For End-Stage Liver Disease (MELD) score [Time frame: Up to 2 years]
  • Hepatocellular cancer (HCC) [Time frame: Up to 2 years]

Eligibility criteria

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

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 2 centers
  • Mayo Clinic in Rochester — Rochester
  • Virginia Commonwealth University — Richmond

Identifiers

NCT: NCT05720663 · HM20024296 · 1R01DK129564

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗