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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Wearable Monitoring Device for Heart Failure

    Device

    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.

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Control GroupNo intervention 0 interventions
Group B: Intervention GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hierarchical Composite Outcome (Win Ratio)

A hierarchical composite outcome comparing the intervention and control groups using a win ratio approach. The components are prioritized as follows: (1) cardiovascular death, (2) heart failure hospitalization, (3) Unplanned visit (emergency room or other emergency facilities) requiring intravenous diuretic treatment, and (4) change in NT-proBNP concentration. Participants are compared pairwise, with outcomes evaluated sequentially according to this hierarchy.

Time frame
90 days

Secondary outcomes

1

Proportion of Participants Achieving Target Doses of Guideline-Directed Medical Therapy (GDMT)

Percentage of participants reaching target doses of guideline-directed medical therapy for heart failure during the first 90 days after randomization.

Time frame
90 days
2

Quality of Life Assessed by KCCQ-12

Change in health-related quality of life measured using validated questionnaire : the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

Time frame
Baseline, 90 days,180 days and 365 days
3

Time to First Clinical Event Composite

Time to First Occurrence of Cardiovascular Death, Heart Failure Hospitalization, or Unplanned Visit Requiring Intravenous Diuretic Treatment

Time frame
Up to 365 days
4

Quality of Life Assessed by EQ-5D-5L

Change in health-related quality of life measured using validated questionnaire : the EQ-5D-5L

Time frame
Baseline, 90 days,180 days and 365 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zoll Medical Corporation

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: