NCT05817136

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Eko DUO	Acquisition of a single-lead ECG via patients self-examine themselves twice a week for 12 months.

Timeline

• Start date: 2023-01-11
• Primary completion: 2024-06-11
• Completion: 2024-06-11
• First posted: 2023-04-18
• Last updated: 2023-04-18

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study