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Utilising AI Analysis of Sounds To prEdict heaRt failurE decOmpensation
Sponsor: Cambridge University Hospitals NHS Foundation Trust
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
250
Start Date
2024-08-15
Completion Date
2027-08-15
Last Updated
2024-08-15
Healthy Volunteers
No
Conditions
Interventions
Height, weight, and BMI
Height, weight measurement and BMI calculation
Medical history
Brief medical history including medications/allergies and heart failure related healthcare utilisation over previous 12 months
Physical examination
Brief physical examination
Venous blood samples
Venous blood samples, to include WCC, HB, CRP and NTproBNP
Resting vital signs
HR, BP, RR, oxygen saturations on air)
Transthoracic echocardiogram
LVEF, IVC collapsibility, LV filling pressure, PA pressure
Sound recordings
Sound recordings (voice/cough/chest) recorded with the in-built microphone in a smartphone
Lung ultrasound
Lung ultrasound
KCCQ questionnaire
Kansas City Cardiomyopathy Questionnaire
ASCEND-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
Composite Everest congestion score
A shortened version of the original 18-point score from the EVEREST trial
Bio impedance and total body water measurement
Bio impedance and total body water measurement using TANITA device