A Study to Assess Multidomain Endpoints of an ECG Patch (D1840M00072)
Research type
Research Study
Full title
Clinical observational study of remote, non-invasive, multidomain endpoints in patients recovering from acute decompensated heart failure
IRAS ID
330309
Contact name
Iain Squire
Contact email
Sponsor organisation
AstraZeneca UK Ltd
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This study aims to evaluate the utility of a wearable heart monitoring patch (VivaLINK) 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 (Enrolment/Screening) will assess the participant’s eligibility for participating in the study and for collecting baseline data immediately prior to discharge following hospitalisation for ADHF. Participants will be trained and receive a VivaLink 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 a VivaLink 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.REC name
North West - Haydock Research Ethics Committee
REC reference
23/NW/0234
Date of REC Opinion
1 Aug 2023
REC opinion
Favourable Opinion