A Study to Assess Multidomain Endpoints of an ECG Patch

Launched by ASTRAZENECA · Jan 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a wearable heart monitoring patch designed to help collect important information about heart health in patients with sudden, severe heart failure, known as acute decompensated heart failure. The goal is to see if this patch can provide useful data that could lead to better ways to test new heart medications in the future. The study will take place at a single hospital in the UK and aims to include up to 80 adults who have recently been hospitalized for this condition.

To be eligible, participants need to be at least 18 years old and have a confirmed diagnosis of heart failure. They should also be willing to attend a few visits for training and follow-up, which will involve wearing the ECG patch at home for several days. Participants will have a total of three visits: the first to enroll and get the patch, a second visit about two months later for more monitoring, and a final review of their health records without needing to come back to the hospital. This study is a valuable step toward improving heart disease treatments, and all participants will provide informed consent before joining.

Gender

ALL

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.