A Study to Assess Multidomain Endpoints of an ECG Patch

Acute Decompensated Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06243029
• Other study ID #: D1840M00072
• Status: Recruiting
• Start date: January 8, 2024
• Est. completion date: May 14, 2025

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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-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. - 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 14, 2025
• Est. primary completion date: May 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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
• Active severe infection: individuals with an active severe infection, as determined by the PI's clinical judgment, will not be eligible for study participation
• Hypersensitivity to patch adhesive/ materials in the patch
• Skin condition or damage that prevents wearing of the patch.

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Research Site	Leicester

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in patch-measured variables between baseline and follow-up at 6-8 weeks (multiple variables) using the ECG patch.		6-8 weeks
Secondary	Data completeness overall and per ECG patch variable, participant adherence, signal to noise ratio, day versus night assessment of quality using the ECG patch.		6-8 weeks
Secondary	Correlation between a change in ECG patch variables (multiple) and change in KCCQ at 6-8 weeks after discharge from hospital following admission for ADHF.		6-8 weeks
Secondary	Correlation between clinical parameters e.g. NT-pro BNP, KCCQ, BP, HR and the patch variables using data from Visit 1 (multiple comparisons).		6-8 weeks
Secondary	Correlation between change in NT-proBNP, BP, HR, body weight, peripheral oedema extent, NYHA class etc. and change in the patch variables (multiple comparisons).		6-8 weeks
Secondary	Correlation between change in one minute sit to stand test, frailty score, hand grip test and the change in patch variables (multiple comparisons).		6-8 weeks