Study identifier:D1840M00072
ClinicalTrials.gov identifier:NCT06243029
EudraCT identifier:N/A
CTIS identifier:N/A
Clinical observational study of remote, non-invasive, multidomain endpoints in patients recovering from acute decompensated heart failure
Acute Decompensated Heart Failure
N/A
No
-
All
80
Observational
18 Years - n/a
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Apr 2025 by AstraZeneca
AstraZeneca
-
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
Location
Status
Location
Leicester, United Kingdom, LE3 9PQ
Status
Recruiting
Location
Cambridge, United Kingdom, CB2 0QQ
Status
Recruiting
Location
Harefield, United Kingdom, UB9 6JH
Status
Recruiting
Arms | Assigned Interventions |
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