Monitoring liver health in patients with Nonalcoholic Steatohepatitis and cirrhosis
Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis
This study is testing new ways to monitor liver health in people with Nonalcoholic Steatohepatitis and cirrhosis to see if they can better predict complications and improve care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Virginia Commonwealth University Academic / other |
| Locations | 2 sites (Rochester, Minnesota and 1 other locations) |
| Trial ID | NCT05720663 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adult patients diagnosed with Nonalcoholic Steatohepatitis associated with compensated cirrhosis.
Not a fit: Patients with other chronic liver diseases, significant alcohol use, or those who have previously experienced liver decompensation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of liver decompensation, allowing for timely interventions and improved patient outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using advanced imaging techniques for liver disease monitoring.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Rochester, Minnesota and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.