MyoVista vs NT-proBNP HF referral Comparison

• Research type

  Research Study

• Full title

  Comparing MyoVista wavECG to NT-proBNP for Heart Failure Referral

• IRAS ID

  305528

• Contact name

  Badrinathan Chandrasekaran

• Contact email

  badri.chandrasekaran1@nhs.net

• Sponsor organisation

  Great Western Hospital NHS Foundation Trust

• Clinicaltrials.gov Identifier

  NCT05068154

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  This clinical study across several recruiting sites using the MyoVista wavECG and looking at its ability to reduce referrals from primary-care (GPs) patients to secondary-care (hospitals) for the diagnosis of heart failure in direct comparison to the blood test BNP/NT-proBNP - the current way. There is no intervention (device/ drug) being used, the Myovista ECG is a replacement for the current ECG in use, the difference being the additional information it is more advanced and can show potential poor heart function more accurately.
  
  The study will consist of a single visit for all borderline or abnormal blood test study subjects to hospital for a referral echo as part of the NHS Heart Failure pathway. After this the subject’s participation in the trial will conclude unless longitudinal study inclusion criteria were met during first GP Visit.

  Patients who had a Normal BNP or NT-proBNP test measure, but who provided a positive MyoVista wavECG test result where Borderline, Positive and Highly Positive are considered “positive” for heart function abnormalities, will be have a notes review for any future revisit to primary or secondary care for suspicion of cardiovascular disease onset for a period of 24 mths.

  For the study duration, the MyoVista wavECG test will be replacing the conventional 12-lead ECG device. All BNP/NT-proBNP blood tests are requested and performed as part of the current NICE guidelines for the NHS heart failure pathway. Patient referrals will be based on BNP/NT-proBNP results only. The MyoVista will not be used for referral purposes and any additional tests such as MRI or ultrasound imaging will only be performed as part of the patient's routine care.

  We discussed this with the MHRA and they have advised as the test is CE marked and not being used for diagnosis, it does not require this study to be notified to them.

• REC name

  West Midlands - South Birmingham Research Ethics Committee

• REC reference

  21/WM/0262

• Date of REC Opinion

  17 Dec 2021

• REC opinion

  Further Information Favourable Opinion