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

Heart Failure Clinical Trial

— (PLANE-HF)  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05817136
• Other study ID #: 22HH7900
• Status: Recruiting
• Start date: January 11, 2023
• Est. completion date: June 11, 2024

Study information

• Verified date: April 2023
• Source: Imperial College London
• Contact: Abdullah Alrumayh
• Phone: +447412335336
• Email: a.alrumayh21[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 11, 2024
• Est. primary completion date: June 11, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Diagnostic Test:
• Eko DUO
Acquisition of a single-lead ECG via patients self-examine themselves twice a week for 12 months.

Locations

Country	Name	City	State
United Kingdom	Imperial College London	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 18 months
Secondary	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	Up to 18 months