NCT06243029

A Study to Assess Multidomain Endpoints of an ECG Patch

Clinical Observational Study of Remote, Non-invasive, Multidomain Endpoints in Patients Recovering From Acute Decompensated Heart Failure

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 54 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 three hospitals, it is non-randomised (not chosen by chance), exploratory, study in the United Kingdom. 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-Screening/Screening/Enrolment) will assess the participant's 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. * 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

Conditions

• Acute Decompensated Heart Failure

Interventions

Type	Name	Description
DEVICE	ECG Patch	Wearable ECG Patch designed to record and transmit physiological parameters to a mobile device or a data cloud. The device stores data locally in a memory cache designed for \>96 hours of continuous data. It continuously records a one-lead ECG and has a three-axis accelerometer. On-board algorithms use those data to compute heart rate, heart rate variability, RR-interval, respiratory rate, and an activity level indicator. The company also provides optional arrhythmia detection and reporting services, the results of which may be delivered to healthcare professionals.

Timeline

• Start date: 2024-01-08
• Primary completion: 2026-03-13
• Completion: 2026-03-13
• First posted: 2024-02-06
• Last updated: 2026-03-25

Locations

3 sites across 1 country: United Kingdom