Incidence of Vascular Disease in Patients with AIH
Research type
Research Study
Full title
Do patients with autoimmune hepatitis (AIH) have an excessive incidence of cardio- and cerebrovascular disease and is this related to corticosteroid treatment?
IRAS ID
307046
Contact name
Sarah Flatley
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Autoimmune hepatitis (AIH) is a non-infectious liver disease, caused by the immune system damaging the liver. Untreated, AIH is a serious and fatal disease. Drug treatment (usually steroids) dampens down the immune system, and greatly improves outcome. However, steroids have side effects. Patients usually gain weight and may develop diabetes. Sometimes, blood pressure rises, and fat levels in the blood and liver increase. These side effects may increase the risk of vascular disease, leading to serious conditions such as angina, heart attacks and strokes. Patients with other steroid treated conditions (such as rheumatoid arthritis) have a higher rate of vascular disease compared to the general population. Here, we wish to see if this is also true in patients with AIH and if there is a link with steroid therapy. If so, this would help drive the development of newer non-steroid treatments.
Sheffield, Birmingham and Kings College Hospital Liver Units treat many patients with AIH. In this study, we aim to see if vascular disease in patients attending these units is more common than in a “control” group of patients, without AIH.
In patients with AIH under our care, we will collect information from Hospital Episodes Statistics (HES) on hospital admissions due to vascular diseases. This will be compared with similar information on a larger “control” group of people who do not have AIH. This “control” group will be chosen randomly from the HES database but will be matched with the AIH patients for region, age and sex.
By comparing patients and controls, we hope to find out if patients with AIH have an “excessive” risk of vascular disease, compared to the general population. If this is so, we will then examine if this is related to their steroid treatment, or to other factors (such as body weight or diabetes).
REC name
South Central - Oxford C Research Ethics Committee
REC reference
22/SC/0381
Date of REC Opinion
1 Nov 2022
REC opinion
Further Information Favourable Opinion