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

NCT06397833 | Recruiting

• 1 other identifier: 334837
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Conditions

Heart Failure; Decompensated Heart Failure

Keywords

heart failure; decompensated heart failure; acorai; artificial intelligence; machine learning generisation; machine learning generization

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  1 year

Study Arms (1)

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.

Device: Acorai ICPM system

Interventions

Acorai ICPM system DEVICE

Patient will have the handheld Acorai ICPM system placed on their chest, for a period of 5 minutes for sensor recording time

Decompensated Heart Failure Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Subjects medically fit for discharge following an admission to Hospital with decompensated heart failure requiring intravenous diuretic therapy
• Subject is willing and physically able to comply with the specified evaluations as per clinical investigation plan, as assessed by the investigator.
• Subject is able to provide written consent to participate in the study

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Harefield Hospital

Uxbridge, Middlesex, UB9 6JH, United Kingdom

RECRUITING

Related Publications (7)

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  PMID: 32188648 BACKGROUND

• Nagai 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.

  PMID: 30228905 BACKGROUND

• Jones 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.

  PMID: 31523902 BACKGROUND

• Mace 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.

  PMID: 37138811 BACKGROUND

• Koehler 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.

  PMID: 30230666 BACKGROUND

• Gardner 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.

  PMID: 15737757 BACKGROUND

• Ahlgrim 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.

  PMID: 36233773 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Owais Dar, MB ChB MD Res

CONTACT

01895828933; o.dar@rbht.nhs.uk

Ramey Assaf, MBBS BMedSci

CONTACT

01895828933; r.assaf@rbht.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 3, 2024
• Study Start: April 29, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 8, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)