Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05817136
Status:
RECRUITING
Last Update Posted:
2023-04-18
First Post:
2023-04-04
Brief Title:
Prospective Longitudinal Evaluation of AI-ECG in a NEwly Diagnosed Heart Failure
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Prospective Longitudinal Evaluation of AI-ECG in a NEwly Diagnosed Heart Failure
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLANE-HF
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None