Heart FailureNCT06397833
A Prospective, Observational, Single Centre Study to Assess the Feasibility of the Data Harvested by the Acorai Intracardiac Pressure Monitoring (ICPM) System in Predicting Prognosis in Patients Discharged From Hospital After Treatment for Acute Decompensated Heart Failure
An observational study of Heart Failure and Decompensated Heart Failure, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Acorai is developing the Acorai Heart Monitor, a handheld electronic device for monitoring pressures inside the heart in a non-invasive manner, by placing the device on the chest of a patient. Currently these intracardiac pressures are measured in an invasive way, during a right heart catheterisation procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Decompensated Heart Failure
- What is being tested?
- Acorai ICPM system
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Apr 2024to 1 Feb 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study population will include all subjects, over the age of 18 years, who have been admitted to hospital with decompensated heart failure, requiring intravenous diuretic therapy.
Who may be able to join
None listed.
Who cannot join
- Pregnancy
- Discretionary exclusion when, in the opinion of the investigator, the inclusion of a potential subject is not in their best interest or not in the interest of compliant performance of the clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Harefield Hospital
Uxbridge, Middlesex, UB9 6JH
About this study
Acorai is developing the Acorai Heart Monitor, a handheld electronic device for monitoring pressures inside the heart in a non-invasive manner, by placing the device on the chest of a patient. Currently these intracardiac pressures are measured in an invasive way, during a right heart catheterisation procedure. This procedure carries risks to the patient. There is a clinical need for a non -invasive, easy to use, tool to monitor patients that suffer from heart failure. The study aim is to use the Acorai device to collect the intracardiac pressure measurements from patients admitted to hospital with heart failure and who are awaiting discharge home. Using the data, we will assess the feasibility of the Acorai derived cardiac output measurements, and assess what data best predicts survival, death, or major adverse cardiac events (MACE)
Read the detailed description
There is a need for the development of a tool that can help to identify those HF patients at risk of deterioration. The ideal tool would be quick, easy to use, non-invasive, inexpensive and can be performed by any healthcare practitioner or patient themselves (i.e. point of care testing).
The Acorai Heart Monitor device is an extended smartphone case equipped with a combination of microphonic sensors, inertial measurement units, electrocardiographic sensors and photoplethysmography sensor, in a configuration that is designed to enhance low frequency sound and seismic signals pertaining to intracardiac pressure. Each sensor technology has been validated to minimize the risk to the patient. Sensor data is collected to provide clinicians with the patients intracardiac pressures. This is performed by placing the monitoring device on the chest, with a small smart-wrist watch, for a period of five minutes in the supine position. A feasibility study showed Acorai device cardiac output measurements correlate highly with the gold standard right heart catheterisation (RHC) cardiac output measurement.
Intracardiac pressure monitoring is important in HF patients. Studies also show that raised right atrial pressure and pulmonary capillary wedge pressure are predictors of worse outcomes with increased risk of death, cardiovascular hospitalisation or transplantation. Clinicians can only gather intracardiac pressure measurements by undertaking a RHC procedure with fluoroscopy guidance. However, this is an invasive procedure, with radiation exposure, that carries risks including bleeding, stroke, infection and pneumothorax.
This is a prospective, observational, single-site, non-randomised, non-significant risk, single arm, clinical investigation designed to collect non-invasive cardiac output measurements from the Acorai Heart Monitor device The objective of the study is to assess the feasibility of the Acorai ICPM system to predict survival and hospitalisation at 1 year in hospitalised heart failure patients deemed medically fit for discharge.
- Conditions
- Heart Failure, Decompensated Heart Failure
- Being tested
- Acorai ICPM system
- Keywords
- heart failure, decompensated heart failure, acorai, artificial intelligence, machine learning generisation, machine learning generization
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acorai ICPM systemDevice
Patient will have the handheld Acorai ICPM system placed on their chest, for a period of 5 minutes for sensor recording time
| Study group | Role | What they receive |
|---|---|---|
| Decompensated Heart Failure Group | Patient has been admitted to hospital with decompensated heart failure, received at least one dose of an intravenous diuretic, and are awaiting discharge home following their treatment. Receives: Device: Acorai ICPM system |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the feasibility of the Acorai ICPM system to predict survival and hospitalisation at 1 year in hospitalised heart failure patients deemed medically fit for discharge.
Measured: 1 year
Secondary outcomes (2)
To assess the feasibility of the Acorai ICPM system to predict Major adverse cardiac events (MACE) 1 year in hospitalised heart failure patients deemed medically fit for discharge.
MACE includes: acute coronary syndrome (ACS), stroke, cardiovascular related death, heart failure related admission, arrythmia, heart transplantation, mechanical circulatory support
Measured: 1 year
To evaluate which of the measurements provided by the Acorai ICPM system (PASP, mPAP, PADP, mPCWP, mRAP, CO, SV and PVR) best predict prognosis.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start29 Apr 2024
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397833
- Sponsor's protocol ID
- 334837
- Status last verified
- Apr 2024
- First submitted
- 29 Apr 2024
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chahal RS, Chukwu CA, Kalra PR, Kalra PA. Heart failure and acute renal dysfunction in the cardiorenal syndrome. Clin Med (Lond). 2020 Mar;20(2):146-150. doi: 10.7861/clinmed.2019-0422.
PubMed 32188648Nagai T, Sundaram V, Rothnie K, Quint JK, Shoaib A, Shiraishi Y, Kohsaka S, Piper S, McDonagh TA, Hardman SMC, Goda A, Mizuno A, Kohno T, Rigby AS, Yoshikawa T, Clark AL, Anzai T, Cleland JGF. Mortality after admission for heart failure in the UK compared with Japan. Open Heart. 2018 Sep 11;5(2):e000811. doi: 10.1136/openhrt-2018-000811. eCollection 2018.
PubMed 30228905Jones NR, Roalfe AK, Adoki I, Hobbs FDR, Taylor CJ. Survival of patients with chronic heart failure in the community: a systematic review and meta-analysis. Eur J Heart Fail. 2019 Nov;21(11):1306-1325. doi: 10.1002/ejhf.1594. Epub 2019 Sep 16.
PubMed 31523902Mace MI. A Novel Multisensor Device for Absolute Intracardiac Pressure Measurement, Detection, and Management of Heart Failure. JACC Basic Transl Sci. 2023 Apr 24;8(4):377-379. doi: 10.1016/j.jacbts.2023.02.001. eCollection 2023 Apr. No abstract available.
PubMed 37138811Koehler F, Koehler K, Deckwart O, Prescher S, Wegscheider K, Winkler S, Vettorazzi E, Polze A, Stangl K, Hartmann O, Marx A, Neuhaus P, Scherf M, Kirwan BA, Anker SD. Telemedical Interventional Management in Heart Failure II (TIM-HF2), a randomised, controlled trial investigating the impact of telemedicine on unplanned cardiovascular hospitalisations and mortality in heart failure patients: study design and description of the intervention. Eur J Heart Fail. 2018 Oct;20(10):1485-1493. doi: 10.1002/ejhf.1300. Epub 2018 Sep 19.
PubMed 30230666Gardner RS, Henderson G, McDonagh TA. The prognostic use of right heart catheterization data in patients with advanced heart failure: how relevant are invasive procedures in the risk stratification of advanced heart failure in the era of neurohormones? J Heart Lung Transplant. 2005 Mar;24(3):303-9. doi: 10.1016/j.healun.2004.01.010.
PubMed 15737757Ahlgrim C, Kocher S, Minners J, Jander N, Savarese G, Neumann FJ, Arentz T, Jadidi A, Mueller-Edenborn B. Pulmonary Capillary Wedge Pressure during Exercise Is Prognostic for Long-Term Survival in Patients with Symptomatic Heart Failure. J Clin Med. 2022 Oct 6;11(19):5901. doi: 10.3390/jcm11195901.
PubMed 36233773
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Single Centre Study to Assess the Feasibility of the Data Harvested by the Acorai Intracardiac Pressure Monitoring (ICPM) System in Predicting Prognosis in Patients Discharged From Hospital After Treatment for Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT06397833
- Acronym / sponsor ID
- 334837
- Conditions
- Heart Failure, Decompensated Heart Failure
- Keywords
- heart failure, decompensated heart failure, acorai, artificial intelligence, machine learning generisation, machine learning generization
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 3 May 2024 (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.
Acorai is developing the Acorai Heart Monitor, a handheld electronic device for monitoring pressures inside the heart in a non-invasive manner, by placing the device on the chest of a patient. Currently these intracardiac pressures are measured in an invasive way, during a right heart catheterisation procedure. This procedure carries risks to the patient. There is a clinical need for a non -invasive, easy to use, tool to monitor patients that suffer from heart failure. The study aim is to use the Acorai device to collect the intracardiac pressure measurements from patients admitted to hospital with heart failure and who are awaiting discharge home. Using the data, we will assess the feasibility of the Acorai derived cardiac output measurements, and assess what data best predicts survival, death, or major adverse cardiac events (MACE)
Detailed description
There is a need for the development of a tool that can help to identify those HF patients at risk of deterioration. The ideal tool would be quick, easy to use, non-invasive, inexpensive and can be performed by any healthcare practitioner or patient themselves (i.e. point of care testing).
The Acorai Heart Monitor device is an extended smartphone case equipped with a combination of microphonic sensors, inertial measurement units, electrocardiographic sensors and photoplethysmography sensor, in a configuration that is designed to enhance low frequency sound and seismic signals pertaining to intracardiac pressure. Each sensor technology has been validated to minimize the risk to the patient. Sensor data is collected to provide clinicians with the patients intracardiac pressures. This is performed by placing the monitoring device on the chest, with a small smart-wrist watch, for a period of five minutes in the supine position. A feasibility study showed Acorai device cardiac output measurements correlate highly with the gold standard right heart catheterisation (RHC) cardiac output measurement.
Intracardiac pressure monitoring is important in HF patients. Studies also show that raised right atrial pressure and pulmonary capillary wedge pressure are predictors of worse outcomes with increased risk of death, cardiovascular hospitalisation or transplantation. Clinicians can only gather intracardiac pressure measurements by undertaking a RHC procedure with fluoroscopy guidance. However, this is an invasive procedure, with radiation exposure, that carries risks including bleeding, stroke, infection and pneumothorax.
This is a prospective, observational, single-site, non-randomised, non-significant risk, single arm, clinical investigation designed to collect non-invasive cardiac output measurements from the Acorai Heart Monitor device The objective of the study is to assess the feasibility of the Acorai ICPM system to predict survival and hospitalisation at 1 year in hospitalised heart failure patients deemed medically fit for discharge.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decompensated Heart Failure Group | – | Device: Acorai ICPM systemPatient has been admitted to hospital with decompensated heart failure, received at least one dose of an intravenous diuretic, and are awaiting discharge home following their treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include all subjects, over the age of 18 years, who have been admitted to hospital with decompensated heart failure, requiring intravenous diuretic therapy.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Pregnancy
- Discretionary exclusion when, in the opinion of the investigator, the inclusion of a potential subject is not in their best interest or not in the interest of compliant performance of the clinical trial
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 |
|---|---|---|
| Acorai ICPM systemPatient will have the handheld Acorai ICPM system placed on their chest, for a period of 5 minutes for sensor recording time | Device | Decompensated Heart Failure Group |
Primary outcome
To assess the feasibility of the Acorai ICPM system to predict survival and hospitalisation at 1 year in hospitalised heart failure patients deemed medically fit for discharge.
Time frame: 1 year
2 secondary outcomes
To assess the feasibility of the Acorai ICPM system to predict Major adverse cardiac events (MACE) 1 year in hospitalised heart failure patients deemed medically fit for discharge.
Time frame: 1 year
To evaluate which of the measurements provided by the Acorai ICPM system (PASP, mPAP, PADP, mPCWP, mRAP, CO, SV and PVR) best predict prognosis.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Background: PubMed 32188648Chahal RS, Chukwu CA, Kalra PR, Kalra PA. Heart failure and acute renal dysfunction in the cardiorenal syndrome. Clin Med (Lond). 2020 Mar;20(2):146-150. doi: 10.7861/clinmed.2019-0422.
- Background: PubMed 30228905Nagai T, Sundaram V, Rothnie K, Quint JK, Shoaib A, Shiraishi Y, Kohsaka S, Piper S, McDonagh TA, Hardman SMC, Goda A, Mizuno A, Kohno T, Rigby AS, Yoshikawa T, Clark AL, Anzai T, Cleland JGF. Mortality after admission for heart failure in the UK compared with Japan. Open Heart. 2018 Sep 11;5(2):e000811. doi: 10.1136/openhrt-2018-000811. eCollection 2018.
- Background: PubMed 31523902Jones NR, Roalfe AK, Adoki I, Hobbs FDR, Taylor CJ. Survival of patients with chronic heart failure in the community: a systematic review and meta-analysis. Eur J Heart Fail. 2019 Nov;21(11):1306-1325. doi: 10.1002/ejhf.1594. Epub 2019 Sep 16.
- Background: PubMed 37138811Mace MI. A Novel Multisensor Device for Absolute Intracardiac Pressure Measurement, Detection, and Management of Heart Failure. JACC Basic Transl Sci. 2023 Apr 24;8(4):377-379. doi: 10.1016/j.jacbts.2023.02.001. eCollection 2023 Apr. No abstract available.
- Background: PubMed 30230666Koehler F, Koehler K, Deckwart O, Prescher S, Wegscheider K, Winkler S, Vettorazzi E, Polze A, Stangl K, Hartmann O, Marx A, Neuhaus P, Scherf M, Kirwan BA, Anker SD. Telemedical Interventional Management in Heart Failure II (TIM-HF2), a randomised, controlled trial investigating the impact of telemedicine on unplanned cardiovascular hospitalisations and mortality in heart failure patients: study design and description of the intervention. Eur J Heart Fail. 2018 Oct;20(10):1485-1493. doi: 10.1002/ejhf.1300. Epub 2018 Sep 19.
- Background: PubMed 15737757Gardner RS, Henderson G, McDonagh TA. The prognostic use of right heart catheterization data in patients with advanced heart failure: how relevant are invasive procedures in the risk stratification of advanced heart failure in the era of neurohormones? J Heart Lung Transplant. 2005 Mar;24(3):303-9. doi: 10.1016/j.healun.2004.01.010.
- Background: PubMed 36233773Ahlgrim C, Kocher S, Minners J, Jander N, Savarese G, Neumann FJ, Arentz T, Jadidi A, Mueller-Edenborn B. Pulmonary Capillary Wedge Pressure during Exercise Is Prognostic for Long-Term Survival in Patients with Symptomatic Heart Failure. J Clin Med. 2022 Oct 6;11(19):5901. doi: 10.3390/jcm11195901.
- 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.
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 and Decompensated Heart Failure, run by Royal Brompton & Harefield NHS Foundation Trust 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 0 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: looking for participants now, as of the sponsor's last update on 8 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Owais Dar, MB ChB MD Res (01895828933, o.dar@rbht.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the feasibility of the Acorai ICPM system to predict survival and hospitalisation at 1 year in hospitalised heart failure patients deemed medically fit for discharge. (time frame: 1 year). 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 NCT06397833, which also lists 7 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 8 Apr 2025.