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A Study to Assess Multidomain Endpoints of an ECG Patch

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clinicaltrials.gov/study/NCT06243029
Is a
‌
Clinical study
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Clinical Study attributes

NCT Number
NCT062430290
Health Conditions in Trial
Acute decompensated heart failure
Acute decompensated heart failure
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Trial Recruitment Size
800
Trial Sponsor
AstraZeneca
AstraZeneca
0
Clinical Trial Start Date
January 8, 2024
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Primary Completion Date
May 14, 2025
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Study Completion Date
May 14, 2025
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Clinical Trial Study Type
Observational0
Observational Clinical Trial Type
Other0
Observational Study Perspective
Prospective0
Official Name
Clinical Observational Study of Remote, Non-invasive, Multidomain Endpoints in Patients Recovering From Acute Decompensated Heart Failure0
Last Updated
February 6, 2024
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Study 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 (Enrolment/Screening) will assess the participant's eligibility for participating in the study and for collecting baseline data immediately prior to discharge 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

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