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Utilising AI Analysis of Sounds To prEdict heaRt failurE decOmpensation

Status: Recruiting
Location: See location...
Intervention Type: Other, Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
Cambridge University Hospitals NHS Foundation Trust
RECRUITING
Cambridge
Contact Information
Primary
Erdem Demir
erdem.demir1@nhs.net
+44 1223 256621
Backup
Heike Templin
heike.templin@nhs.net
+44 1223 250874
Time Frame
Start Date: 2024-09-18
Estimated Completion Date: 2027-08-15
Participants
Target number of participants: 250
Treatments
Patients with heart failure
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).
Related Therapeutic Areas
Sponsors
Collaborators: University of Cambridge
Leads: Cambridge University Hospitals NHS Foundation Trust

This content was sourced from clinicaltrials.gov