Heart Failure(PLANE-HF)NCT05817136
Prospective Longitudinal Evaluation of AI-ECG in a NEwly Diagnosed Heart Failure
An observational study of Heart Failure, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Background: Heart Failure (HF) is a condition in which the heart can no longer adequately pump blood around the body. The number of patients diagnosed with HF is increasing, consuming 4% of the NHS budget, and deadlier than most cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Eko DUO
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jan 2023to 11 Jun 2024
- Phase
- Observational
- 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
- Adult, Older adult
Study population: * Group 1: Newly diagnosed HFrEF patient with coronary causes. * Group 2: Newly diagnosed HFrEF patient with non-coronary causes.
Who may be able to join
- Age 18 years or above
- Able to give informed consent
- Newly diagnosed with HFrEF (i.e., LVEF below 40%) assessed by a consultant cardiologist within the past two weeks.
Who cannot join
- Any chest wound, skin pathology or other feature that would prohibit routine Eko DUO examination.
- Participants who have been diagnosed with HF previously
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College London
London
Abdullah Alrumayh
About this study
Background:
Heart Failure (HF) is a condition in which the heart can no longer adequately pump blood around the body. The number of patients diagnosed with HF is increasing, consuming 4% of the NHS budget, and deadlier than most cancers. Most patients suffer from HF with reduced Ejection Fraction (HFrEF), where adequate treatment can improve quality of life and survival. Less than 50% of patients receive gold standard NHS guided medication and less than 20% receive appropriate monitoring (via echocardiography surveillance).
Read more
This study looks at the use of a 'smart stethoscope' (Eko DUO), a stethoscope that uses information collected from the heart in the form of electrical (ECG) and sounds (phonocardiogram, PCG) waveforms, to predict the pumping function of the heart via artificial intelligence (AI-ECG).
Aims:
By using the smart stethoscope, this study evaluates whether the use of an easy-to-use home self-monitoring programme can:
- Provide a solution for the current poor compliance of NHS echocardiogram surveillance programmes for people with newly diagnosed HF
- Provide real-time assessment of heart function in response to medication changes
- Improve the health economic and health outcomes of HF in the NHS
Methods:
80 participants with newly diagnosed HFrEF, due to pre-existing heart disease and non-heart related causes, will be identified by the clinical team at Imperial College NHS Trust and obtain consent for the research team to approach them. All consented participants will receive a smart stethoscope and instructions for twice-weekly, 15-second self-examination for 3-months. Participants will also be invited for an additional echocardiogram at 6 weeks post-diagnosis, in addition to the routine, standard of care NHS echocardiogram surveillance for HF.
- Conditions
- Heart Failure
- Being tested
- Eko DUO
- Keywords
- Heart failure, Remote monitoring, Machine learning
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eko DUODiagnostic test
Acquisition of a single-lead ECG via patients self-examine themselves twice a week for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| coronary HF aetiology | Patients with coronary HF Receives: Diagnostic Test: Eko DUO | |
| non-coronary HF aetiology | Patients with non-coronary HF Receives: Diagnostic Test: Eko DUO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive analysis of trends and association of raw AI-ECG signals changes that correlate with HF progression.
- AI-ECG signal changes with LV impairment.
- AI-ECG signal changes with medication optimization.
- AI-ECG signal changes with healthcare episodes.
Measured: Up to 18 months
Secondary outcomes (1)
Sensitivity and specificity of AI-ECG to predict HF progression
- AI-ECG prediction of HF trajectory deterioration or improvement.
- AI-ECG prediction of clinical congestive HF
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start11 Jan 2023
- Primary completion11 Jun 2024 (estimated)
- Study completion11 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Peters, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817136
- Sponsor's protocol ID
- 22HH7900
- Acronym
- (PLANE-HF)
- Status last verified
- Apr 2023
- First submitted
- 4 Apr 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Longitudinal Evaluation of AI-ECG in a NEwly Diagnosed Heart Failure
- ClinicalTrials.gov ID
- NCT05817136
- Acronym / sponsor ID
- (PLANE-HF) / 22HH7900
- Conditions
- Heart Failure
- Keywords
- Heart failure, Remote monitoring, Machine learning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 11 Jun 2024 (estimated)
- Study completion
- 11 Jun 2024 (estimated)
- First posted
- 18 Apr 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.
Background:
Heart Failure (HF) is a condition in which the heart can no longer adequately pump blood around the body. The number of patients diagnosed with HF is increasing, consuming 4% of the NHS budget, and deadlier than most cancers. Most patients suffer from HF with reduced Ejection Fraction (HFrEF), where adequate treatment can improve quality of life and survival. Less than 50% of patients receive gold standard NHS guided medication and less than 20% receive appropriate monitoring (via echocardiography surveillance).
This study looks at the use of a 'smart stethoscope' (Eko DUO), a stethoscope that uses information collected from the heart in the form of electrical (ECG) and sounds (phonocardiogram, PCG) waveforms, to predict the pumping function of the heart via artificial intelligence (AI-ECG).
Aims:
By using the smart stethoscope, this study evaluates whether the use of an easy-to-use home self-monitoring programme can:
- Provide a solution for the current poor compliance of NHS echocardiogram surveillance programmes for people with newly diagnosed HF
- Provide real-time assessment of heart function in response to medication changes
- Improve the health economic and health outcomes of HF in the NHS
Methods:
80 participants with newly diagnosed HFrEF, due to pre-existing heart disease and non-heart related causes, will be identified by the clinical team at Imperial College NHS Trust and obtain consent for the research team to approach them. All consented participants will receive a smart stethoscope and instructions for twice-weekly, 15-second self-examination for 3-months. Participants will also be invited for an additional echocardiogram at 6 weeks post-diagnosis, in addition to the routine, standard of care NHS echocardiogram surveillance for HF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coronary HF aetiology | – | Diagnostic Test: Eko DUOPatients with coronary HF |
| non-coronary HF aetiology | – | Diagnostic Test: Eko DUOPatients with non-coronary HF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * Group 1: Newly diagnosed HFrEF patient with coronary causes. * Group 2: Newly diagnosed HFrEF patient with non-coronary causes.
Key inclusion criteria (3 listed)
- Age 18 years or above
- Able to give informed consent
- Newly diagnosed with HFrEF (i.e., LVEF below 40%) assessed by a consultant cardiologist within the past two weeks.
Key exclusion criteria (2 listed)
- Any chest wound, skin pathology or other feature that would prohibit routine Eko DUO examination.
- Participants who have been diagnosed with HF previously
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 |
|---|---|---|
| Eko DUOAcquisition of a single-lead ECG via patients self-examine themselves twice a week for 12 months. | Diagnostic test | coronary HF aetiology, non-coronary HF aetiology |
Primary outcome
Descriptive analysis of trends and association of raw AI-ECG signals changes that correlate with HF progression.
Time frame: Up to 18 months
1. AI-ECG signal changes with LV impairment. 2. AI-ECG signal changes with medication optimization. 3. AI-ECG signal changes with healthcare episodes.
1 secondary outcome
Sensitivity and specificity of AI-ECG to predict HF progression
Time frame: Up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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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 Peters 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?
An observational study of Heart Failure, 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 3 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 18 Apr 2023. 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?
Contact Abdullah Alrumayh (+447412335336, a.alrumayh21@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive analysis of trends and association of raw AI-ECG signals changes that correlate with HF progression. (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2023.