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NCT06243029Completed

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

Source: ClinicalTrials.gov · Last updated 25 Mar 2026

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Observational
Enrollment
54 (actual)
First submitted
2 Oct 2023
Start date
8 Jan 2024
Primary completion date
13 Mar 2026
Lead sponsor
AstraZeneca
NCT number
NCT06243029

What you commit to

  • Study type: Observational
  • Participants enrolled: 54
  • From 8 Jan 2024 to the primary completion date, 13 Mar 2026
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Receiving renal replacement therapy
  • Currently receiving chemotherapy
  • Receiving end-of-life care

Other illness

  • Implanted cardiac (or other) device in-situ, cardiac pacemaker, defibrillator, or other implanted electronic devices or other ventricular assist device in situ
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
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Coordinator of this site? Confirm its status
CambridgeUnited KingdomUnknown status
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Coordinator of this site? Confirm its status
HarefieldUnited KingdomUnknown status
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Coordinator of this site? Confirm its status
LeicesterUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.