Status:

NOT_YET_RECRUITING

Utilising AI Analysis of Sounds To prEdict heaRt failurE decOmpensation

Lead Sponsor:

Cambridge University Hospitals NHS Foundation Trust

Collaborating Sponsors:

University of Cambridge

Conditions:

Heart Failure

Eligibility:

All Genders

18+ years

Brief Summary

Heart failure impacts more than 2% of people in the UK (United Kingdom) and leads to about 5% of emergency hospital visits. Patients might have slowly worsening symptoms or suddenly face acute decompe...

Detailed Description

Heart failure is a common condition in which the heart is unable to deliver the desired cardiac output either due to a weakened or stiff heart muscle. It affects more than 2% of the UK population (the...

Eligibility Criteria

Inclusion

  • Male or Female, aged 18 years or above.
  • Diagnosed with chronic stable heart failure NYHA Class 3 or 4 (either during most recent cardiology/heart failure clinic visit, or ADHF during recent/current hospitalization).
  • Participant is willing and able to give informed consent for participation in the study.
  • Participant has a smartphone device and can download a purposely designed mobile application on their phone (with guidance from the study investigators) or is willing to have sound recordings via a smartphone device loaned for the purpose of the study.

Exclusion

  • Unable to provide consent
  • Patients requiring continuous oxygen therapy at flow rates that cannot be provided through nasal cannula
  • Patients with currently known pneumonia
  • Patients with known significant pulmonary disease including asthma, COPD, pulmonary fibrosis/interstitial lung disease, pulmonary hemorrhage.
  • Patients with current Pulmonary embolus
  • Patients with other intercurrent acute symptomatic illness (e.g., viral/bacterial infection) at time of recording
  • Patients requiring continuous oxygen therapy at flow rates that cannot be provided through nasal cannula
  • Patients with tracheostomy or who have undergone a surgical procedure to the head/neck/larynx which would affect the normal functioning of the vocal cords.
  • Aphasic
  • Patients excluded at PI discretion

Key Trial Info

Start Date :

August 15 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

August 15 2027

Estimated Enrollment :

250 Patients enrolled

Trial Details

Trial ID

NCT06555757

Start Date

August 15 2024

End Date

August 15 2027

Last Update

August 15 2024

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