BIOPEF v1.0
Research type
Research Study
Full title
Biomarkers in patients with suspected HFPEF (BIOPEF)
IRAS ID
328629
Contact name
Ross Campbell
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Heart failure (HF) is a condition that is estimated to affect over 64 million people internationally.
The current blood tests used in the diagnostic pathway for heart failure, most notably N-terminal pro-B-type natriuretic-peptide (NT-proBNP), have some limitations.
Patients may have values below established cut-off levels of these tests and still have heart failure. This may result in under-diagnosis. This is suggested to be a particular issue in individuals with obesity.
We propose to recruit 1208 patients with suspected heart failure who have had an NT-proBNP test performed in the community. Patients will be identified following their referral to tertiary services at the NHS Greater Glasgow and Clyde heart failure diagnostic pathway (HFDP), and through searches of biochemistry laboratory records or a National Research Scotland (NRS) Primary Care Network (PCN) team search of primary care records. Patients will be invited for review at NHS Greater Glasgow and Clyde clinical or research sites.
The study will consist of one or two research visits. Each patient will have a history, physical examination, electrocardiogram (ECG) and rest echocardiogram (cardiac ultrasound) performed. Blood and urine tests for established and novel biomarkers will be taken.
If a patient's initial echocardiogram is normal, an exercise echocardiogram will be performed at a second visit to further evaluate for abnormal changes in cardiac pressures during exercise, which may indicate heart failure with preserved ejection fraction (HFpEF).
Each patient will be reviewed by a clinician with expertise in heart failure. The diagnosis of heart failure will be made or excluded after study assessments. Where required, further clinical assessments, treatments and follow-up will be arranged.
The accuracy of different blood and urine tests will be tested and compared. This may help in the discovery and development of new and improved tests which are more accurate for diagnosing or excluding heart failure.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
23/YH/0136
Date of REC Opinion
23 Jun 2023
REC opinion
Favourable Opinion