Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ 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)

Locations
United States
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Contact Information
Primary
Mohammad S Siddiqui, MD
mohammad.siddiqui@vcuhealth.org
804-828-4060
Time Frame
Start Date: 2023-04-19
Estimated Completion Date: 2027-12
Participants
Target number of participants: 240
Treatments
nonalcoholic steatohepatitis (NASH)
Adult patients nonalcoholic steatohepatitis (NASH)
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Virginia Commonwealth University

This content was sourced from clinicaltrials.gov