Remote Monitoring and Optimization of Heart Failure Therapy
ConditionHeart Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorZoll Medical Corporation
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥18 years
Ability and willingness to provide written informed consent and comply with study procedures
Hospital admission for acute heart failure with dyspnea at rest and pulmonary congestion on chest X-ray, and other signs and/or symptoms of heart failure such as edema and/or positive rales on auscultation.
All measures within 24 hours prior to randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm.
Disqualifiers
Age < 18 years
Clearly documented intolerance to high doses (≥50% of target dose) of beta-blockers.
Clearly documented intolerance to high doses (≥50% of target dose) of RAS blockers (both ACEi and ARB).
Mechanical ventilation (not including CPAP/BIPAP) in the 24 hours prior to Screening.
Trial design
Treatments tested in this trial
- Wearable Monitoring Device for Heart Failure
Treatment groups
800 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov