Assessing the efficacy and safety of venesection in patients with dysmetabolic iron overload syndrome and non-alcoholic fatty liver disease

Marie Sinclair0 个研究点目标入组 15 人开始时间: 2022年1月27日最近更新: 2024年1月22日

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•Non-alcoholic fatty liver disease evident radiologically (hepatic steatosis on ultrasonography, computed tomography or magnetic resonance of the liver, or controlled attenuation parameter >248 dB/m on transient elastography) and/or histological evidence of steatosis on liver biopsy
•- Serum ferritin >600 micrograms/L
•- Histological evidence of hepatic iron overload identified by Perl's stain for iron on liver biopsy

•Anaemia (Hb less than 120 g/L for women, less than 130 g/L for men)
•Hereditary haemochromatosis defined by C282Y homozygosity or C282Y/H63D compound heterozygosity
•Alcohol consumption greater than 140 grams per week for men, or greater than 100 grams per week for women
•Weight loss greater than 5% body weight 6 months prior to study inclusion
•Chronic kidney disease stage 3 or greater, defined by eGFR less than 30 mL/min
•Heart failure with left ventricular ejection fraction less than 40%, or ischaemic heart disease
•Decompensated cirrhosis, defined by Child Pugh class B or C
•Alternate cause of liver disease other than NAFLD
•Concurrent use of steatogenic medications (eg. tamoxifen, methotrexate, amiodarone, prednisolone)
•Inadequate venous access to facilitate regular venesection as assessed by apharesis unit
•HbA1c greater than 10%
•Coagulopathy such that risk of liver biopsy unacceptable
•Change in diabetic medication within 3 months
•Those who do not speak English as a first language

发起方

Marie Sinclair