RecruitingNCT06555757

Utilising AI Analysis of Sounds To prEdict heaRt failurE decOmpensation


Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrollment

250 participants

Start Date

Sep 18, 2024

Study Type

OBSERVATIONAL

Conditions

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 decompensated heart failure (ADHF), marked by intense difficulty in breathing due to fast-developing lung congestion. This is a serious emergency requiring in-hospital treatment and monitoring. Once stable, patients usually have a phase where symptoms remain constant. But as time goes on, those with heart failure often face more frequent and prolonged episodes of ADHF. Fluid build-up (pulmonary congestion) in the lungs is a key issue in heart failure, and catching it early helps avoid unexpected hospital stays. Spotting these early signs outside the hospital can be tough, as symptoms aren't always clear. Study investigators are working on a new, non-invasive way to identify these early signs using AI (artificial intelligence) to analyse subtle changes in a patient's voice, cough, and breathing sounds. This tool will act as an early warning for patients and their heart care teams, allowing quicker treatment. This could make heart failure episodes less severe and reduce the need for hospital visits. This research has two parts. First, a small pilot trial with up to 50 patients. The findings will guide and inform a larger study involving up to 200 patients. From this larger study, investigators will develop the final version of the AI algorithm. The results from the Part A and Part B of this research will guide the investigators in planning a future clinical trial. This trial will confirm if the AI algorithm can be effectively used as a medical tool for heart failure care within the NHS (National Health Service). Study investigators will seek the necessary ethical approval before starting this trial.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria10

  • 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

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Interventions

OTHERHeight, weight, and BMI

Height, weight measurement and BMI calculation

OTHERMedical history

Brief medical history including medications/allergies and heart failure related healthcare utilisation over previous 12 months

OTHERPhysical examination

Brief physical examination

DIAGNOSTIC_TESTVenous blood samples

Venous blood samples, to include WCC, HB, CRP and NTproBNP

OTHERResting vital signs

HR, BP, RR, oxygen saturations on air)

DIAGNOSTIC_TESTTransthoracic echocardiogram

LVEF, IVC collapsibility, LV filling pressure, PA pressure

OTHERSound recordings

Sound recordings (voice/cough/chest) recorded with the in-built microphone in a smartphone

DIAGNOSTIC_TESTLung ultrasound

Lung ultrasound

OTHERKCCQ questionnaire

Kansas City Cardiomyopathy Questionnaire

OTHERASCEND-HF score

An in-hospital congestion score which risk stratifies patients admitted with worsening heart failure, developed for the Acute study of clinical effectiveness of Nesiritide in decompensated heart failure trial

OTHERComposite Everest congestion score

A shortened version of the original 18-point score from the EVEREST trial

DIAGNOSTIC_TESTBio impedance and total body water measurement

Bio impedance and total body water measurement using TANITA device


Locations(1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, United Kingdom

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NCT06555757


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