Clinical trial NCT05720663: Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis
Official title: Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nonalcoholic Steatohepatitis
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-02-09
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with presence of NAFLD associated cirrhosis.

Brief 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.

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.

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)

Primary outcomes:
measure: Number of deaths
timeFrame: Up to 2 years
measure: Incidents of variceal hemorrhage
timeFrame: Up to 2 years
measure: Incidents of ascites
timeFrame: Up to 2 years
measure: Hepatic Encephalopathy (HE)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Model For End-Stage Liver Disease (MELD) score
timeFrame: Up to 2 years
measure: Hepatocellular cancer (HCC)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Mohammad S Siddiqui, MD
role: PRINCIPAL_INVESTIGATOR
References: