Exploratory Analysis of Enhanced Liver Function (ELF) Test to Detect Early Fatty Liver in High Risk Population

Fatty Liver Clinical Trial

Official title:

Exploratory Analysis of Enhanced Liver Function (ELF) Test to Detect Early Fatty Liver in High Risk Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06225193
• Other study ID #: 022.HEP.2023.D
• Status: Recruiting
• Start date: June 20, 2023
• Est. completion date: June 23, 2024

Study information

• Verified date: January 2024
• Source: Methodist Health System
• Contact: Kavya Vinod Mankulangara, PharmD
• Phone: 214-947-4681
• Email: MHSIRB[@]mhd.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this initial investigator-initiated retrospective study, aim to analyze the enhanced liver fibrosis (ELF) scores in this high-risk population for NAFLD/nonalcoholic steatohepatitis(NASH)-related fibrosis. Study define 'high-risk' to include metabolic syndrome, which can be further defined by an atherosclerotic cardiovascular disease (ASCVD) score >7.5, any diagnosis of hyperlipidemia, history of coronary artery disease, history of heart failure, hypertension and/or type 2 diabetes. Study would also like to compare the performance of this score with historical methods of fibrosis assessment, where applicable, including vibration-controlled transient elastography, magnetic resonance elastography, blood markers and liver biopsy. Study will assess the impact of ELF scores on predicting liver events in the time, have used it and determine if diet, lifestyle changes and/or pharmacotherapy will improve serial ELF scores. Will also seek to understand how ELF scores are distributed in our community.

Description:

Methodist Health System consists of nine hospitals and over one hundred clinics that serve 7% to 10% of patients in the Dallas metropolitan. In November 2021, adopted the use of ELF tests in patients who had risk factors for NAFLD/NASH based on abnormal liver enzymes, metabolic risk factors, and evidence of hepatosteatosis on imaging. There is a knowledge gap in the literature when it comes to ELF scores in our population and the data we collect in this study will contribute to filling that knowledge gap.

Historically, assessment of fibrosis has been accomplished with FibroScan,elastography or liver biopsy. However, these tests are not widely available in most clinics, and can be invasive and costly. At present, the two primary inexpensive and non-invasive alternatives are the fibrosis-4 (FIB-4) and ELF scores, which employ algorithms that utilize routine lab draws. While a low FIB-4 score has a negative predictive value of 90% for advanced fibrosis, it does not provide a risk assessment of liver-related events. For this reason, the study explore the newer ELF serum test as a non-invasive, more affordable and available means to detect patients with developing fibrosis and as a predictor of liver-related outcomes that could be easily used in a primary care setting. This will better risk-stratify this patient population at the primary care level, without need for invasive and expensive testing, and will guide appropriate referrals to Hepatology.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 23, 2024
• Est. primary completion date: June 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age: = 18 years

• NAFLD/NASH and non-NAFLD/NASH patients who have had an assessment with ELF score at Methodist Dallas Medical Center from November 2021 to December 2023.

Exclusion Criteria:

• Patients with incomplete data and those lost to follow up.

Related Conditions & MeSH terms

• Fatty Liver

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enhanced Liver Fibrosis (ELF )scores	Will measure the ELF scores-Reference range 7.14-9.55, the lowest value means better and highest value would mean worst	6 months
Primary	Instances of hospital admission for ascites, edema/anasarca, portal hypertensive-related bleeding or encephalopathy	Number of hospital admissions for ascites, edema/anasarca, portal hypertensive-related bleeding or encephalopathy	6 months
Primary	Demographics	age (years), gender (male/female), race (Caucasian, Black, Hispanic, Asian, Other)	6 months
Primary	Instances of comorbidities	Patients with hypertension(HTN), Hypersensitivity Lung Disease(HLD), Coronary Artery Disease(CAD),Heart Failure( HF), Atherosclerotic cardiovascular disease (ASCVD), Type 2 Diabetes Mellitus(T2DM) as comorbidities	6 months
Secondary	Abnormalities in Liver ultrasound (U/S) findings	rate of liver damage	6 months
Secondary	Abnormalities in Liver biopsy results	Rate of cancerous cells in liver	6 months