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Remote Monitoring and Optimization of Heart Failure Therapy

NCT07622472 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2026-06-26

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Zoll Medical Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2028-08-01
Completion
2029-08-01
FDA Device
Yes

Countries

  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07622472 on ClinicalTrials.gov