DUO-EF-19 V1.0

• Research type

  Research Study

• Full title

  Diagnosis of Heart Failure in the Post-COVID-19 Clinic, Primary Care and Hospital Setting Using a Digital Stethoscope with AI ECG

• IRAS ID

  285417

• Contact name

  Nicholas Peters

• Contact email

  n.peters@imperial.ac.uk

• Sponsor organisation

  Imperial College London

• Clinicaltrials.gov Identifier

  NCT04601415

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  AIMS

  - To validate detection of left ventricular ejection fraction (LVEF) above or below 40% using single-lead ECG interpreted by machine learning algorithm (DUO-EF) compared to gold-standard investigations for calculating LVEF (echocardiography [echo], and a subgroup in cardiac MRI [cMRI])

  - To conduct a real-world evaluation of DUO-EF detection of LVEF above or below 40% in the primary care and COVID-19 follow up clinic setting; validated against subsequent gold standard investigations
  
  - To evaluate the positive and negative-predictive value of DUO-EF at 24 months

  METHODS

  Head-to-head comparison of DUO-EF against gold standard investigation (echo and cMRI) for classifying LVEF<40%; in unselected patients attending for routine echocardiography (main study group) and cardiac MRI (subgroup) as part of their routine clinical care

  Point-of-care DUO-EF in patients where GP suspects new heart failure and comparison with:
  subsequent DUO-EF at time of gold-standard investigation (if indicated as standard of care)
  ejection fraction as calculated by gold-standard investigation

  Point-of-care DUO-EF in patients attending COVID-19 follow up clinic where clinician suspects new heart failure and comparison with:
  Subsequent DUO-EF at time of gold-standard investigation for HF
  Ejection fraction as calculated by gold-standard investigation

  Telephone call follow-up at 24 months for all patients with DUO-EF suggestive of HFrEF but normal gold standard investigations; telephone follow-up at 24 months for all patients in COVID-19 follow up group who had a negative DUO-EF result

  1.) Primary: Sensitivity, specificity for DUO-EF detecting LVEF above or below 40%

  2.) Secondary:
  DUO-EF performance against subgroup LVEF calculated by cardiac MRI
  Consistency of DUO-EF result at point-of-care in GP practice (‘real world’ use where GP suspects new heart failure) against repeat DUO-EF at time of gold-standard investigation
  Number of patients with LVEF <40% identified by DUO-EF in the COVID-19 follow-up clinic with subsequent echo confirming LVEF <40%.
  Development of LVEF <40% at 24 months in participants with initial DUO-EF suggestive of LVEF <40% but gold standard investigations LVEF >40% i.e. can DUO-EF predict future development of LVEF <40%
  DUO-EF point-of-care determination of LVEF<40% in comparison with the components of the established NICE pathway (BNP result)

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  21/LO/0051

• Date of REC Opinion

  5 Feb 2021

• REC opinion

  Further Information Favourable Opinion