Evaluating a wearable ECG patch for heart failure monitoring
Clinical Observational Study of Remote, Non-invasive, Multidomain Endpoints in Patients Recovering From Acute Decompensated Heart Failure
AstraZeneca · NCT06243029
This study is testing a wearable ECG patch to see if it can help monitor heart health in people recently hospitalized for severe heart failure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AstraZeneca (industry) |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Cambridge and 2 other locations) |
| Trial ID | NCT06243029 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of a wearable ECG patch designed to monitor various heart-related metrics in patients with acute decompensated heart failure. Conducted at University Hospitals of Leicester NHS Trust in the UK, the study will involve up to 80 participants who have recently been hospitalized for severe heart failure symptoms. Participants will wear the ECG patch for approximately two months, with one follow-up visit after discharge to gather data on the patch's utility in improving heart failure management and drug development processes.
Who should consider this trial
Good fit: Ideal candidates include men and women aged 18 and older with a confirmed diagnosis of acute decompensated heart failure.
Not a fit: Patients receiving renal replacement therapy, those with implanted cardiac devices, or those currently undergoing chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the monitoring and management of heart failure, leading to better treatment outcomes for patients.
How similar studies have performed: While this approach is exploratory, similar studies using wearable technology for heart monitoring have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cambridge and 2 other locations
- Research Site — Cambridge, United Kingdom (RECRUITING)
- Research Site — Harefield, United Kingdom (RECRUITING)
- Research Site — Leicester, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Prof Iain Squire, BSc MBChB MD — Glenfield Hospital, University Hospitals of Leicester NHS Trust
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Decompensated Heart Failure, Heart Failure, ECG Patch