NCT05817136

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2024

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

1.4 years

First QC Date

April 4, 2023

Last Update Submit

April 4, 2023

Conditions

Heart Failure

Keywords

Heart failureRemote monitoringMachine learning

Outcome Measures

Primary Outcomes (1)

  • Descriptive analysis of trends and association of raw AI-ECG signals changes that correlate with HF progression.

    1. AI-ECG signal changes with LV impairment. 2. AI-ECG signal changes with medication optimization. 3. AI-ECG signal changes with healthcare episodes.

    Up to 18 months

Secondary Outcomes (1)

  • Sensitivity and specificity of AI-ECG to predict HF progression

    Up to 18 months

Study Arms (2)

coronary HF aetiology

Patients with coronary HF

Diagnostic Test: Eko DUO

non-coronary HF aetiology

Patients with non-coronary HF

Diagnostic Test: Eko DUO

Interventions

Eko DUODIAGNOSTIC_TEST

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

coronary HF aetiologynon-coronary HF aetiology

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Group 1: Newly diagnosed HFrEF patient with coronary causes. * Group 2: Newly diagnosed HFrEF patient with non-coronary causes.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College London

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Nicholas Peters

    Imperial College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdullah Alrumayh

CONTACT

+447412335336a.alrumayh21@imperial.ac.uk

Nicholas Peters

CONTACT

+44 (0)20 7594 1880n.peters@imperial.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2023

First Posted

April 18, 2023

Study Start

January 11, 2023

Primary Completion

June 11, 2024

Study Completion

June 11, 2024

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations

GB(1)