Role of Lisinopril in Preventing The Progression of Non-Alcoholic Fatty Liver Disease (NAFLD): Relief-NAFLD
This phase II trial investigates how well lisinopril may work in preventing the progression of non-alcoholic fatty liver disease (NAFLD). NAFLD is a condition where there is an accumulation of fatty cells in the liver. NAFLD increases a person's risk of developing liver cancer. Liver fibrosis is the common finding of chronic liver diseases leading to reduced liver function. Lisinopril is a medication that is commonly used to treat high blood pressure. Lisinopril may help to decrease liver fibrosis. The purpose of this trial is to find out what effect, if any, lisinopril has on a patient's risk of developing liver cancer.
• Male and female subjects \>= 18 years of age
• Clinical diagnosis of nonalcoholic steatohepatitis (NASH) assessed by the presence of body imaging criteria (ultrasound, computed tomography \[CT\], or magnetic resonance imaging \[MRI\]), or liver biopsy up to six months prior to enrollment without suspicious nodules or cancer
• Screening transient elastography liver stiffness \>= 12 kPa (which correlates with F3 fibrosis and more) and \< 25 kPa. Historic transient elastography within 0-4 weeks prior to the date of the screening visit is acceptable. Patients with liver stiffness \>= 10 and \< 12 kPA with clinical evidence of cirrhosis based on any of the following criteria would also be eligible.
‣ Imaging diagnosis of nodular liver with splenomegaly or recanalized umbilical vein
⁃ MRE \>= 5 kPa
⁃ Fibrosis (FIB)-4 \> 2.67 or platelet count \< 150,000 mL
⁃ Liver biopsy \< 5 years with meta-analysis of histological data in viral hepatitis (METAVIR) stage 4 or Ishak stage 5-6
• Controlled attenuation parameter score or liver steatosis analysis (LiSA) of \>= 260 dB/m and any single component of metabolic syndrome (ATP3 criteria) or historic liver biopsy within 0 - 6 months prior to the date of the screening visit consistent with nonalcoholic steatohepatitis (NASH) (defined as the presence of steatosis, inflammation, and ballooning), with stage 3-4 fibrosis according to the NASH Clinical Research Network classification (or equivalent)
• Leukocytes \>= 3,000/microliter
• Absolute neutrophil count \>= 1,500/microliter
• Platelets \>= 75,000/microliter
• Total bilirubin within normal institutional limits unless the patient has Gilbert's syndrome
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 8 x institutional upper limit of institutional limits
• Glomerular filtration rate \> 30 ml/min
• International normalized ratio (INR) =\< 1.3 unless the patient is on a therapeutic medication
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
• The effects of lisinopril has been shown to be teratogenic in animal models. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
• Ability to understand and the willingness to sign a written informed consent document. If a participant has impaired decision-making capacity (IDMC), their legal representative may replace them in this process
• Systolic blood pressure \>= 90 and =\< 160 mm/Hg. Diastolic blood pressure \>= 60 and =\< 110 mm/Hg