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Remote Monitoring and Optimization of Heart Failure Therapy
Sponsor: Zoll Medical Corporation
Summary
Heart failure is a condition in which the heart cannot pump blood effectively, often leading to symptoms such as shortness of breath and fluid retention. After hospitalization for heart failure, patients remain at high risk of worsening symptoms, emergency visits, and hospital readmission. This study is designed to evaluate whether using a wearable monitoring device, called the Heart Failure Management System (HFMS), can help improve the management of patients after a recent hospitalization for heart failure. Participants in this study will be randomly assigned to one of two groups. One group will receive standard medical care alone. The other group will receive standard medical care in combination with the HFMS device. The HFMS device is worn on the body and continuously collects information such as heart rate, breathing, activity level, and signs of fluid accumulation. These data are reviewed by the clinical care team and may help detect early worsening of heart failure. Participants will wear the device for 90 days (if assigned to the device group) and will be followed for up to one year. During the study, information will be collected on serious health events such as death, hospitalizations, emergency visits, and changes in heart failure status, as well as quality of life. The goal of this study is to determine whether this monitoring approach can improve outcomes for patients with heart failure by enabling earlier and more effective clinical management.
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
800
Start Date
2026-10-01
Completion Date
2029-08-01
Last Updated
2026-06-26
Healthy Volunteers
No
Conditions
Interventions
Wearable Monitoring Device for Heart Failure
Participants assigned to the intervention group will use a noninvasive wearable physiological monitoring device (Heart Failure Management System, HFMS) designed to continuously collect data related to cardiopulmonary status, including heart rate, respiratory parameters, activity levels, and indicators of fluid status (Thoraic Fluid Index = TFI). Clinical care teams perform regular reviews of device-derived data and may respond to alerts or trends suggestive of worsening heart failure. Based on these data, the care team may adjust patient management, including modification of guideline-directed medical therapy or scheduling of follow-up assessments. The device does not deliver therapy and is used to support clinical decision-making in the outpatient management of heart failure.
Locations (9)
CHU Nancy
Nancy, Grand Est, France
Justus-Liebig University Giessen
Giessen, Germany
Policlinico Casilino
Roma, Italy
UMC Utrecht
Utrecht, Netherlands
PIM MSWiA Hospital
Warsaw, Poland
Hospital Universitario 12 de Octubre
Madrid, Spain
Uppsala University Hospital
Uppsala, Sweden
University Zurich
Zurich, Switzerland
Southampton University Hospital NHS Foundation Trust
Southampton, United Kingdom