Clinical utility of an oral fluid NT-proBNP in heart failure

  • Research type

    Research Study

  • Full title

    Investigating diagnostic and screening utility of an oral fluid NT-proBNP in patients with suspected heart failure.

  • IRAS ID

    323647

  • Contact name

    Michael Fisher

  • Contact email

    michael.fisher@rlbuht.nhs.uk

  • Sponsor organisation

    Royal Liverpool and Broadgreen University Hospital NHS Trust

  • Duration of Study in the UK

    1 years, 11 months, 31 days

  • Research summary

    The study involves testing the clinical utility of an oral fluid heart failure biomarker NT-proBNP.

    The following diagnostic parameters of an oral fluid NT-proBNP biomarker will be assessed as part of the study: diagnostic cut-off level, sensitivity, specificity as well as positive and negative predictive values. Such data will validate the use of NT-proBNP biomarker to rule in or rule out heart failure in a clinical setting.

    Undifferentiated patients who are referred to the outpatient cardiology clinic with suspected heart failure diagnosis are eligible to take part in the study.

    The study will be conducted at the Royal Liverpool Hospital, where oral fluid sample will be taken from each study participant. Blood samples will be also taken from the same study participants as part of the routine care to test serum NT-proBNP levels.

    The study will last for approximately one year, until we generate enough data to test the diagnostic applicability of an oral fluid NT-proBNP biomarker in patients with suspected heart failure.

  • REC name

    London - Chelsea Research Ethics Committee

  • REC reference

    23/PR/0233

  • Date of REC Opinion

    3 May 2023

  • REC opinion

    Further Information Favourable Opinion