Monitoring liver health in patients with Nonalcoholic Steatohepatitis and cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research investigates improved methods for monitoring patients with Nonalcoholic Steatohepatitis (NASH) who have compensated cirrhosis. The study aims to identify the onset of liver decompensation by incorporating additional procedures such as Spleen Stiffness Measurement during a Fibroscan, and advanced MRI techniques. By comparing these methods to standard care, the study seeks to enhance the prediction of complications associated with liver disease. The goal is to provide better management strategies for patients at risk of liver failure.

Why it matters

Who can join: the full rules

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)

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting
• Virginia Commonwealth University
  Richmond, Virginia, United States Recruiting

Study contacts

• Principal investigator: Mohammad S Siddiqui, MD — Virginia Commonwealth University
• Study coordinator: Mohammad S Siddiqui, MD
• Email: mohammad.siddiqui@vcuhealth.org
• Phone: 804-828-4060

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.