Heart FailureTRICORDERNCT05987670
Triple Cardiovascular Disease Detection With an Artificial Intelligence-enabled Stethoscope
A study testing AI-stethoscope in people with Heart Failure and Heart Valve Diseases, run by Imperial College London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Valve Diseases, Atrial Fibrillation
- What is being tested?
- AI-stethoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Oct 2023to 23 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Poor WiFi and/or mobile data connectivity within primary care consulting rooms
- No face-to-face patient consultations
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NHS North West London Integrated Care System
London
About this study
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.
Read more
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:
- Increases overall detection of heart failure
- Reduces the proportion of patients being diagnosed with heart failure following an emergency hospital admission
- 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 detailed 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.
- Conditions
- Heart Failure, Heart Valve Diseases, Atrial Fibrillation, Heart Murmurs, Congestive Heart Failure, Heart Failure With Reduced Ejection Fraction
- Being tested
- AI-stethoscope
- Keywords
- cluster randomized controlled trial, artificial intelligence, digital health, cardiology, primary care
- Medical subject headings
- Heart Failure, Heart Valve Diseases, Atrial Fibrillation, Heart Murmurs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-stethoscopeDevice
Also called Eko DUO, Eko Core 500, Eko EAS
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
- Delivery and setup
- Smartphone app installation and login
- Pairing of all clinician smartphones with all AI-stethoscopes in the same practice
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 Receives: Device: AI-stethoscope |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of heart failure (co-primary)
Difference in incidence of coded new diagnoses of heart failure (HF)
Measured: 24 months
Ratio of route to diagnosis of heart failure (co-primary) between emergency and community-based pathways
Difference in ratio of the incidence of coded diagnoses of HF via hospital admission-based versus community-based pathways.
Measured: 24 months
Secondary outcomes (11)
Incidence of atrial fibrillation
New coded diagnoses of atrial fibrillation (AF)
Measured: 24 months
Incidence of valvular heart disease
New coded diagnoses of valvular heart disease (VHD)
Measured: 24 months
Cost-consequence (AF)
Cost-consequence analysis (form of health economic evaluation) for diagnosis of atrial fibrillation, stratified by route to diagnosis. Presented in pounds sterling.
Measured: 24 months
Cost-consequence (HFrEF)
Cost-consequence analysis (form of health economic evaluation) for diagnosis of HFrEF, stratified by route to diagnosis. Presented in pounds sterling.
Measured: 24 months
Cost-consequence (VHD)
Cost-consequence analysis (form of health economic evaluation) for diagnosis of VHD, stratified by route to diagnosis. Presented in pounds sterling.
Measured: 24 months
Health service utilisation
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.
Measured: 24 months
Proportion of patients prescribed guideline-directed medical therapy
Proportion of patients prescribedguideline-directed medical therapy (HF, AF, VHD)
Measured: 24 months
Device therapy
New implantation of cardiac resynchronisation therapy (CRT) and/or implantable cardioverter-defibrillator (ICD)
Measured: 24 months
Uptake and utilisation
Differential rates of uptake and utilisation of AI-stethoscope in primary care
Measured: 24 months
Determinants of uptake and utilisation
Determinants of utilisation of AI-stethoscope in primary care (clinician questionnaires)
Measured: 24 months
Patient quality of life
Healthy Days at Home (patient-level analysis)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start25 Oct 2023
- Primary completion23 Dec 2025 (estimated)
- Study completion23 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label cluster randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Health Partners (ICHP)
- Responsible party
- Sponsor
- Investigators
- Nicholas S Peters, MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987670
- Sponsor's protocol ID
- 22HH8045
- Acronym
- TRICORDER
- Status last verified
- Jul 2024
- First submitted
- 21 Jul 2023
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bachtiger P, Petri CF, Scott FE, Ri Park S, Kelshiker MA, Sahemey HK, Dumea B, Alquero R, Padam PS, Hatrick IR, Ali A, Ribeiro M, Cheung WS, Bual N, Rana B, Shun-Shin M, Kramer DB, Fragoyannis A, Keene D, Plymen CM, Peters NS. Point-of-care screening for heart failure with reduced ejection fraction using artificial intelligence during ECG-enabled stethoscope examination in London, UK: a prospective, observational, multicentre study. Lancet Digit Health. 2022 Feb;4(2):e117-e125. doi: 10.1016/S2589-7500(21)00256-9. Epub 2022 Jan 5.
PubMed 34998740Bachtiger P, Kelshiker MA, Petri CF, Gandhi M, Shah M, Kamalati T, Khan SA, Hooper G, Stephens J, Alrumayh A, Barton C, Kramer DB, Plymen CM, Peters NS. Survival and health economic outcomes in heart failure diagnosed at hospital admission versus community settings: a propensity-matched analysis. BMJ Health Care Inform. 2023 Mar;30(1):e100718. doi: 10.1136/bmjhci-2022-100718.
PubMed 36921978Kelshiker MA, Bachtiger P, Mansell J, Kramer DB, Nakhare S, Almonte MT, Alrumayh A, Petri CF, Peters A, Costelloe C, Falaschetti E, Barton C, Al-Lamee R, Majeed A, Plymen CM, Peters NS. Triple cardiovascular disease detection with an artificial intelligence-enabled stethoscope (TRICORDER): design and rationale for a decentralised, real-world cluster-randomised controlled trial and implementation study. BMJ Open. 2025 May 21;15(5):e098030. doi: 10.1136/bmjopen-2024-098030.
PubMed 40398956
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple Cardiovascular Disease Detection With an Artificial Intelligence-enabled Stethoscope
- ClinicalTrials.gov ID
- NCT05987670
- Acronym / sponsor ID
- TRICORDER / 22HH8045
- Conditions
- Heart Failure, Heart Valve Diseases, Atrial Fibrillation, Heart Murmurs, Congestive Heart Failure, Heart Failure With Reduced Ejection Fraction
- Keywords
- cluster randomized controlled trial, artificial intelligence, digital health, cardiology, primary care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Imperial College Health Partners (ICHP)
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 23 Dec 2025 (estimated)
- Study completion
- 23 Dec 2025 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Increases overall detection of heart failure
- Reduces the proportion of patients being diagnosed with heart failure following an emergency hospital admission
- 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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label cluster randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: AI-stethoscopeReceive 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 |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Poor WiFi and/or mobile data connectivity within primary care consulting rooms
- No face-to-face patient consultations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-stethoscopeAlso: Eko DUO, Eko Core 500, Eko EASClinicians 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. | Device | Intervention |
Primary outcome
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.
11 secondary outcomes
Incidence of atrial fibrillation
Time frame: 24 months
Incidence of valvular heart disease
Time frame: 24 months
Cost-consequence (AF)
Time frame: 24 months
Cost-consequence (HFrEF)
Time frame: 24 months
Cost-consequence (VHD)
Time frame: 24 months
Health service utilisation
Time frame: 24 months
Proportion of patients prescribed guideline-directed medical therapy
Time frame: 24 months
Device therapy
Time frame: 24 months
Uptake and utilisation
Time frame: 24 months
Determinants of uptake and utilisation
Time frame: 24 months
Patient quality of life
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Background: PubMed 34998740Bachtiger P, Petri CF, Scott FE, Ri Park S, Kelshiker MA, Sahemey HK, Dumea B, Alquero R, Padam PS, Hatrick IR, Ali A, Ribeiro M, Cheung WS, Bual N, Rana B, Shun-Shin M, Kramer DB, Fragoyannis A, Keene D, Plymen CM, Peters NS. Point-of-care screening for heart failure with reduced ejection fraction using artificial intelligence during ECG-enabled stethoscope examination in London, UK: a prospective, observational, multicentre study. Lancet Digit Health. 2022 Feb;4(2):e117-e125. doi: 10.1016/S2589-7500(21)00256-9. Epub 2022 Jan 5.
- Background: PubMed 36921978Bachtiger P, Kelshiker MA, Petri CF, Gandhi M, Shah M, Kamalati T, Khan SA, Hooper G, Stephens J, Alrumayh A, Barton C, Kramer DB, Plymen CM, Peters NS. Survival and health economic outcomes in heart failure diagnosed at hospital admission versus community settings: a propensity-matched analysis. BMJ Health Care Inform. 2023 Mar;30(1):e100718. doi: 10.1136/bmjhci-2022-100718.
- Derived from this study: PubMed 40398956Kelshiker MA, Bachtiger P, Mansell J, Kramer DB, Nakhare S, Almonte MT, Alrumayh A, Petri CF, Peters A, Costelloe C, Falaschetti E, Barton C, Al-Lamee R, Majeed A, Plymen CM, Peters NS. Triple cardiovascular disease detection with an artificial intelligence-enabled stethoscope (TRICORDER): design and rationale for a decentralised, real-world cluster-randomised controlled trial and implementation study. BMJ Open. 2025 May 21;15(5):e098030. doi: 10.1136/bmjopen-2024-098030.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas S Peters, MD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-stethoscope in people with Heart Failure and Heart Valve Diseases, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of heart failure (co-primary) (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05987670, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.