Acute Decompensated Heart Failure
Conditions
Keywords
Acute Decompensated Heart Failure;, Heart Failure;, ECG Patch
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 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
Interventions
DEVICEECG 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.
Sponsors
AstraZeneca
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in patch-measured variables between baseline and follow-up at 6-8 weeks (multiple variables) using the ECG patch. | 6-8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORProf Iain Squire, BSc MBChB MD
Glenfield Hospital, University Hospitals of Leicester NHS Trust
PRINCIPAL_INVESTIGATORDr Owais Dar, MD PhD
Royal Brompton & Harefield Hospitals,Guy's and St Thomas' Foundation Trust
PRINCIPAL_INVESTIGATORDr Joseph Cheriyan, MD PhD
Cambridge University Hospitals NHS Trust
Outcome results
None listed