Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06243029
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2023-10-02
Brief Title:
A Study to Assess Multidomain Endpoints of an ECG Patch
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Clinical Observational Study of Remote Non-invasive Multidomain Endpoints in Patients Recovering From Acute Decompensated Heart Failure
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
This study aims to evaluate the utility of a wearable heart monitoring patch that can be worn on the body to collect various measurements related to heart failure and develop a concept to potentially be used as a new measurement It is crucial to test out new ways that make it easier to do research for new drugs and increase our chances of knowing how well they will work early on in the development process Results from this study will be useful in planning future development programs for drugs aimed at treating patients with heart disease
This study will be conducted in a single hospital it is non-randomised not chosen by chance exploratory study in the United Kingdom University Hospitals of Leicester NHS Trust It aims to involve up to 80 men and women recently admitted due to sudden severe heart failure symptoms Participants will be part of the study for about two months with one hospital visit after discharge as commonly done in heart failure centres
Visit 1 Pre-ScreeningScreeningEnrolment will assess the participants eligibility for participating in the study and for collecting data following hospitalisation for acute decompensated heart failure ADHF Participants will be trained and receive an ECG patch to wear from that moment onwards at home for a period of 4 to 7 days
Visit 2 Follow-up visit will be conducted approximately 6-8 weeks post Visit 1 and this will be the final study-related site visit Participants will receive an ECG patch to wear at home for a second time for a period of 4 to 7 days
Visit 3 Review of Medical Records It is a review of the health status using medical records by the study team The participant is not expected to attend the hospital for any appointments
This study will be conducted in a single hospital it is non-randomised not chosen by chance exploratory study in the United Kingdom University Hospitals of Leicester NHS Trust It aims to involve up to 80 men and women recently admitted due to sudden severe heart failure symptoms Participants will be part of the study for about two months with one hospital visit after discharge as commonly done in heart failure centres
Visit 1 Pre-ScreeningScreeningEnrolment will assess the participants eligibility for participating in the study and for collecting data following hospitalisation for acute decompensated heart failure ADHF Participants will be trained and receive an ECG patch to wear from that moment onwards at home for a period of 4 to 7 days
Visit 2 Follow-up visit will be conducted approximately 6-8 weeks post Visit 1 and this will be the final study-related site visit Participants will receive an ECG patch to wear at home for a second time for a period of 4 to 7 days
Visit 3 Review of Medical Records It is a review of the health status using medical records by the study team The participant is not expected to attend the hospital for any appointments
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None