PLANE-HF

• Research type

  Research Study

• Full title

  Prospective Longitudinal evaluation of AI-ECG in a NEwly diagnosed Heart Failure (PLANE-HF)

• IRAS ID

  318420

• Contact name

  Nicholas Peters

• Contact email

  n.peters@imperial.ac.uk

• Sponsor organisation

  Imperial College London

• Duration of Study in the UK

  1 years, 6 months, 1 days

• Research summary

  Background:
  Heart Failure (HF) is a condition in which the heart can no longer adequately pump blood around the body. The number of patients diagnosed with HF is increasing, consuming 4% of the NHS budget, and deadlier than most cancers. Most patients suffer from HF with reduced Ejection Fraction (HFrEF), where adequate treatment can improve quality of life and survival. Less than 50% of patients receive gold standard NHS guided medication and less than 20% receive appropriate monitoring (via echocardiography surveillance).

  This study looks at the use of a ‘smart stethoscope’ (Eko DUO), a stethoscope that uses information collected from the heart in the form of electrical (ECG) and sounds (phonocardiogram, PCG) waveforms, to predict the pumping function of the heart via artificial intelligence (AI-ECG).

  Aims:
  By using the smart stethoscope, this study evaluates whether the use of an easy-to-use home self-monitoring programme can:
  - Provide a solution for the current poor compliance of NHS echocardiogram surveillance programmes for people with newly diagnosed HF
  - Provide real-time assessment of heart function in response to medication changes
  - Improve the health economic and health outcomes of HF in the NHS

  Methods:
  80 participants with newly diagnosed HFrEF, due to pre-existing heart disease and non-heart related causes, will be identified by the clinical team at Imperial College NHS Trust and obtain consent for the research team to approach them. All consented participants will receive a smart stethoscope and instructions for twice-weekly, 15-second self-examination for 3-months. Participants will also be invited for an additional echocardiogram at 6 weeks post-diagnosis, in addition to the routine, standard of care NHS echocardiogram surveillance for HF.

  Outcomes:
  1. Primary: Analysis trends and changes in raw AI-ECG signal in relation to the heart function, prescribed medications and the frequency of healthcare episodes.
  2. Secondary: Accuracy of AI-ECG to predict HF progression, including prediction of HF trajectory deterioration or improvement, and prediction of HF congestion.

• REC name

  London - South East Research Ethics Committee

• REC reference

  22/LO/0701

• Date of REC Opinion

  9 Dec 2022

• REC opinion

  Further Information Favourable Opinion