POSEIDON
Research type
Research Study
Full title
POSEIDON – Prevalence of systemic inflammation in patients with atherosclerotic cardiovascular disease and heart failure
IRAS ID
333275
Contact name
Yuk-Ki Wong
Contact email
Sponsor organisation
Novo Nordisk
Clinicaltrials.gov Identifier
U1111-1286-3420, UTN
Duration of Study in the UK
1 years, 4 months, 31 days
Research summary
The role of inflammation as a cause of atherosclerosis has long been recognized. C-Reactive protein is a reliable measure of underlying systemic inflammation and is a strong predictor of future cardiovascular events. The high sensitive CRP (hsCRP) assay can detect the small changes in CRP which are relevant at the levels that affect cardiovascular risk but it is not routinely measured and there have been no large studies of the prevalence of elevated hsCRP.
This large, international cross-sectional study of patients with atherosclerotic cardiovascular disease aims to investigate the prevalence of systemic inflammation as measured by hsCRP. Comparisons will be made between different ethnicities,geographical location and other subgroups.
Systemic inflammation is also involved in other diseases such as heart failure, chronic kidney disease (CKD) and non-alcoholic steatohepatitis (NASH). NASH is the most severe manifestation of non-alcoholic fatty liver disease (NAFLD) which is thought to affect more than 25% of adults globally.It is underdiagnosed and is typically silent until advanced and the most common cause of death is atherosclerotic cardiovascular disease.
This study will also investigate hsCRP prevalence in patients with heart failure.
The Fibrosis-4 (FIB-4) index is a blood based diagnostic test and will be used to assess liver fibrosis in all patients. The Enhanced Liver Fibrosis Test (ELF) is a blood test that predicts cirrhosis and other liver events in patients with advanced liver fibrosis and will be measured in patients with a FIB-4 index ≥ 1.3.
Other biomarkers that will be measured are NT-proBNP which is a marker of heart failure and Interleukin 6 (IL-6) which is an upstream biomarker of inflammation which induces CRP production by the liver. The eGFR will be used to assess renal function.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
23/WM/0248
Date of REC Opinion
21 Dec 2023
REC opinion
Further Information Favourable Opinion