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Active, not recruitingNCT05987670ClinicalTrials.gov record

Triple Cardiovascular Disease Detection With an Artificial Intelligence-enabled Stethoscope

Heart Failure · Heart Valve Diseases · Atrial Fibrillation · Heart Murmurs · Congestive Heart Failure · Heart Failure With Reduced Ejection Fraction

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
18 years - Not specified
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
200 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

Heart failure (HF) is a condition in which the heart cannot pump blood adequately. It is increasingly common, consumes 4% of the UK National Health Service (NHS) budget and is deadlier than most cancers. Early diagnosis and treatment of HF improves quality of life and survival. Unacceptably, 80% of patients have their HF diagnosed only when very unwell, requiring an emergency hospital admission, with worse survival and higher treatment costs to the NHS. This is largely because General Practitioners (GPs) have no easy-to-use tools to check for suspected HF, with patients having to rely on a long and rarely completed diagnostic pathway involving blood tests and hospital assessment.

The investigators have previously demonstrated that an artificial intelligence-enabled stethoscope (AI-stethoscope) can detect HF in 15 seconds with 92% accuracy (regardless of age, gender or ethnicity) - even before patients develop symptoms. While the GP uses the stethoscope, it records the heart sounds and electrical activity, and uses inbuilt artificial intelligence to detect HF.

The goal of this clinical trial is to determine the clinical and cost-effectiveness of providing primary care teams with the AI-stethoscope for the detection of heart failure. The main questions it aims to answer are if provision of the AI-stethoscope:

1. Increases overall detection of heart failure
2. Reduces the proportion of patients being diagnosed with heart failure following an emergency hospital admission
3. Reduces healthcare system costs

200 primary care practices across North West London and North Wales, UK, will be recruited to a cluster randomised controlled trial, meaning half of the primary care practices will be randomly assigned to have AI-stethoscopes for use in direct clinical care, and half will not. Researchers will compare clinical and cost outcomes between the groups.

Read the full description

Triple Cardiovascular Disease Detection with Artificial Intelligence-enabled Stethoscope (TRICORDER) is an open label, cluster randomised controlled trial. The aim is to determine whether use of an artificial intelligence-enabled stethoscope (AI-stethoscope) in UK Primary Care improves community-based detection of heart failure (HF), compared with usual care. 200 primary care practices in North West London (UK) will be randomised to receive the AI-stethoscope (intervention arm) or continue with usual care (control arm). The intervention arm will use the AI-stethoscope in routine clinical practice. Outcomes will be measured using pooled primary and secondary care clinical and cost-data, as well as clinician questionnaires.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

  • Primary care practices that care for adult patients and have the ability to request natriuretic peptide blood testing
  • Primary care practices within the NIHR North West London Clinical Research Network or Betsi Cadwaladr University Health Board.

Exclusion Criteria:

  • Poor WiFi and/or mobile data connectivity within primary care consulting rooms
  • No face-to-face patient consultations
Understand screening

Treatment, groups and participation

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Assignment
Random assignment
Masking
No masking
Intervention

Receive 3-6 AI-stethoscopes (Eko DUO, Eko Health Inc, CA, USA) including artificial intelligence software for detection of:

1. Reduced left ventricular ejection fraction \<40%
2. Atrial fibrillation
3. Cardiac murmurs

Device: AI-stethoscope

Control

Usual care

AI-stethoscope DEVICE

Clinicians at practices in the intervention arm will be provided with one session of in-person training in use of the AI-stethoscope within 2 weeks of randomisation, including

1. Delivery and setup
2. Smartphone app installation and login
3. Pairing of all clinician smartphones with all AI-stethoscopes in the same practice
4. Demo of patient examination The AI-stethoscope will be used within its CE/UKCA-marked intended purpose. The clinical guidelines for use have been agreed by the NHS North West London Integrated Care System and Betsi Cadwaladr University Health Board Cardiovascular Executive Groups. Patients will be examined with the AI-stethoscope in accordance with these guidelines, and/or where stethoscope examination is deemed clinically appropriate. Patients will provide verbal consent for examination with the AI-stethoscope as per any physical examination performed by healthcare professionals for direct care, in accordance with UK law and General Medical Council guidelines.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Incidence of heart failure (co-primary)

Time frame: 24 months

Difference in incidence of coded new diagnoses of heart failure (HF)

Ratio of route to diagnosis of heart failure (co-primary) between emergency and community-based pathways

Time frame: 24 months

Difference in ratio of the incidence of coded diagnoses of HF via hospital admission-based versus community-based pathways.

Secondary measures

Incidence of atrial fibrillation

Time frame: 24 months

New coded diagnoses of atrial fibrillation (AF)

Incidence of valvular heart disease

Time frame: 24 months

New coded diagnoses of valvular heart disease (VHD)

Cost-consequence (AF)

Time frame: 24 months

Cost-consequence analysis (form of health economic evaluation) for diagnosis of atrial fibrillation, stratified by route to diagnosis. Presented in pounds sterling.

Cost-consequence (HFrEF)

Time frame: 24 months

Cost-consequence analysis (form of health economic evaluation) for diagnosis of HFrEF, stratified by route to diagnosis. Presented in pounds sterling.

Cost-consequence (VHD)

Time frame: 24 months

Cost-consequence analysis (form of health economic evaluation) for diagnosis of VHD, stratified by route to diagnosis. Presented in pounds sterling.

Health service utilisation

Time frame: 24 months

Health service utilisation for diagnostics e.g. rates of request for echocardiography, electrocardiography, primary care appointments. Collected from NHS organisation business intelligence repositories and UK Trusted Research Environments.

Proportion of patients prescribed guideline-directed medical therapy

Time frame: 24 months

Proportion of patients prescribedguideline-directed medical therapy (HF, AF, VHD)

Device therapy

Time frame: 24 months

New implantation of cardiac resynchronisation therapy (CRT) and/or implantable cardioverter-defibrillator (ICD)

Uptake and utilisation

Time frame: 24 months

Differential rates of uptake and utilisation of AI-stethoscope in primary care

Determinants of uptake and utilisation

Time frame: 24 months

Determinants of utilisation of AI-stethoscope in primary care (clinician questionnaires)

Patient quality of life

Time frame: 24 months

Healthy Days at Home (patient-level analysis)

Other measures

Sensitivity analysis

Time frame: 24 months

Patient-level sensitivity analyses will be performed for patients with abnormal Eko DUO predictions for HF, to identify direct associations between AI-stethoscope predictions and specific diagnostic codes for HF, AF and VHD

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

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1 locations

NHS North West London Integrated Care SystemLondon, United KingdomStatus unknown

Study team and timeline

Lead sponsor
Imperial College London
Study start
Oct 25, 2023 Actual
Primary completion
Jun 23, 2028 Estimated
Study completion
Jun 23, 2028 Estimated
First posted
Aug 14, 2023 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

Triple Cardiovascular Disease Detection With an Artificial Intelligence-enabled Stethoscope

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026