Prospective Longitudinal Evaluation of AI-ECG in a NEwly Diagnosed Heart Failure

NCT ID: NCT05817136

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-11
• Study Completion Date: 2024-06-11

Brief 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. 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.

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

coronary HF aetiology

Patients with coronary HF

Eko DUO

Intervention Type: DIAGNOSTIC_TEST

Acquisition of a single-lead ECG via patients self-examine themselves twice a week for 12 months.

non-coronary HF aetiology

Patients with non-coronary HF

Eko DUO

Intervention Type: DIAGNOSTIC_TEST

Acquisition of a single-lead ECG via patients self-examine themselves twice a week for 12 months.

Interventions

Eko DUO

Acquisition of a single-lead ECG via patients self-examine themselves twice a week for 12 months.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Any chest wound, skin pathology or other feature that would prohibit routine Eko DUO examination.
• Participants who have been diagnosed with HF previously

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicholas Peters

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Imperial College London

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Abdullah Alrumayh

Role: CONTACT

a.alrumayh21@imperial.ac.uk

+447412335336

Nicholas Peters

Role: CONTACT

n.peters@imperial.ac.uk

+44 (0)20 7594 1880

Facility Contacts

Abdullah Alrumayh

Role: primary

Other Identifiers

22HH7900

Identifier Type: -

Identifier Source: org_study_id