A Study to Assess Multidomain Endpoints of an ECG Patch

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Description

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 (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 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

Study Overview

Start Date
January 8, 2024
Completion Date
May 14, 2025
Enrollment
80
Date Posted
February 6, 2024
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Research Site
Leicester LE3 9PQ, United Kingdom

Eligibility

Study Population
Potential study participants will be identified through review of hospital inpatient lists, conversations with healthcare providers and review of medical notes. Participants who meet the study eligibility criteria will be approached whilst still in the hospital but due to be discharged by the research team who will enquire whether they are interested in participating in the study. Up to 80 male and female participants over 18 years old will be enrolled in the study.
Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

Men and women aged 18 years or older
Confirmed diagnosis of heart failure according to the latest ESC criteria
Primary cause of hospitalisation due to decompensated heart failure
Willing and able to complete all visits and assessments as per protocol
Provision of signed and dated, written informed consent before any study-specific procedures.

Exclusion Criteria:

Receiving renal replacement therapy
Implanted cardiac (or other) device in-situ, cardiac pacemaker, defibrillator, or other implanted electronic devices or other ventricular assist device in situ
Currently receiving chemotherapy
Receiving end-of-life care
Antibiotics at discharge or has a severe infection
Hypersensitivity to patch adhesive/ materials in the patch
Skin condition or damage that prevents wearing of the patch.

Study Contact Info

Study Contact Name
AstraZeneca Clinical Study Information Center
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT06243029