Clinical Trials Detalhe

A multi-centre randomised controlled trial to determine the implementation and health care cost of LiverMultiScan vs. routine methodical assessment (standard care) of Non-alcoholic fatty liver disease (NAFLD) across several European countries.

NASH - Nonalcoholic Steatohepatitis

NAFLD

Metabolic Syndrome

Inclusion Criteria: * Male and female patients aged 18-75 years, due to undergo evaluation for suspected non-alcoholic fatty liver disease * Presence of: * elevated liver function tests (ALT, AST or GGT ≥ 1.5 x upper limit of normal and ≤ 5 x upper limit of normal) OR * imaging suggestive of Fatty liver disease. OR Presence of ≥ 3 of the following criteria: 1. insulin resistance or type 2 diabetes mellitus 2. obesity (BMI \> 30 or waist-to-hip ratio \> 1.00 for men / \> 0.85 for women) 3. hypertension (≥ 130/85 mmHg) 4. elevated triglycerides (≥ 1.7 mmol/l) 5. low HDL-cholesterol (\< 1.05 mmol/l for men / \< 1.25 mmol/l for women) * Participant is willing and able to give informed consent for participation in the study. Exclusion Criteria: * The participant may not enter the study if they have any contraindication to magnetic resonance imaging (inc pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia). * Patients with proven liver disease other than NAFLD. * Liver transplantation * Patients that present with clinical signs of chronic liver failure (variceal bleeding, ascites, overt encephalopathy) * Pregnancy * Alcohol over-use/ abuse as determined by local guidelines * Patient with known malignant liver tumours and those with any malignancy with life expectancy \< 36 months * Heart failure NYHA stages II-IV * Severe mental illness * Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study