Clinical trial NCT06243029: A Study to Assess Multidomain Endpoints of an ECG Patch
Official title: Clinical Observational Study of Remote, Non-invasive, Multidomain Endpoints in Patients Recovering From Acute Decompensated Heart Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Decompensated Heart Failure
Keywords: Acute Decompensated Heart Failure;
Heart Failure;
ECG Patch
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-02-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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 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


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
* 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.

Primary outcomes:
measure: Change in patch-measured variables between baseline and follow-up at 6-8 weeks (multiple variables) using the ECG patch.
timeFrame: 6-8 weeks
Secondary outcomes:
measure: Data completeness overall and per ECG patch variable, participant adherence, signal to noise ratio, day versus night assessment of quality using the ECG patch.
timeFrame: 6-8 weeks
measure: 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.
timeFrame: 6-8 weeks
measure: Correlation between clinical parameters e.g. NT-pro BNP, KCCQ, BP, HR and the patch variables using data from Visit 1 (multiple comparisons).
timeFrame: 6-8 weeks
measure: Correlation between change in NT-proBNP, BP, HR, body weight, peripheral oedema extent, NYHA class etc. and change in the patch variables (multiple comparisons).
timeFrame: 6-8 weeks
measure: Correlation between change in one minute sit to stand test, frailty score, hand grip test and the change in patch variables (multiple comparisons).
timeFrame: 6-8 weeks
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Research Site
city: Harefield
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Glenfield Hospital, University Hospitals of Leicester NHS Trust
name: Prof Iain Squire, BSc MBChB MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Brompton & Harefield Hospitals,Guy's and St Thomas' Foundation Trust
name: Dr Owais Dar, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cambridge University Hospitals NHS Trust
name: Dr Joseph Cheriyan, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: