Abstract
Non-Alcoholic Fatty Liver Disease (NAFLD), a progressive liver disease that is closely associated with obesity, type 2 diabetes, hypertension and dyslipidaemia, represents an increasing global public health challenge. There is significant variability in the disease course: the majority exhibit only fat accumulation in the liver but a significant minority develop a necroinflammatory form of the disease (non-alcoholic steatohepatitis, NASH) that may progress to cirrhosis and hepatocellular carcinoma. At present our understanding of pathogenesis, disease natural history and long-term outcomes remain incomplete. There is a need for large, well characterised patient cohorts that may be used to address these knowledge gaps and to support the development of better biomarkers and novel therapies.The European NAFLD Registry is an international, prospectively recruited observational cohort study that aims to establish a large, highly-phenotyped patient cohort and linked bioresource. Here we describe the infrastructure, data management and monitoring plans, and the standard operating procedures implemented to ensure the timely and systematic collection of high-quality data and samples. Already recruiting subjects at secondary/tertiary care centres across Europe, the Registry is supporting the European Union IMI2-funded LITMUS ‘Liver Investigation: Testing Marker Utility in Steatohepatitis’ consortium, which is a major international effort to robustly validate biomarkers that diagnose, risk stratify and/or monitor NAFLD progression and liver fibrosis stage. The European NAFLD Registry has the demonstrable capacity to support research and biomarker development at scale and pace.
Highlights
Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease worldwide and represents a major global public health challenge
[3] Non-Alcoholic Fatty Liver Disease (NAFLD) is a spectrum of progressive liver disease comprising steatosis, in which excessive hepatic fat is present, and non-alcoholic steatohepatitis (NASH), a necroin flammatory form of the condition marked by histological inflammation and hepatocyte ballooning that leads to progressive liver fibrosis
The European NAFLD Registry represents a major international ef fort involving leading secondary/tertiary care centres in Europe, to prospectively recruit patients into an observational study exploring the pathophysiology of progressive liver disease, disease outcomes and associated predictive factors in patients with NAFLD
Summary
Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease worldwide and represents a major global public health challenge. It is characterised by the increased accumulation of hepatic fat (> 5%) and is closely linked with the presence of the me tabolic syndrome and its components: obesity, type 2 diabetes mellitus, hypertension and dyslipidaemia. There are key knowledge gaps, in particular limited clarity on modifiers of disease natural history and an incomplete under standing of disease pathophysiology These issues contribute to the lack of tractable non-invasive biomarkers of disease severity that hinder the diagnosis, risk stratification and monitoring of patients, and the ab sence of approved pharmacological therapies
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