N/A
N=329
Surveillance and Alert-based Multiparameter Monitoring to Reduce Worsening Heart Failure Events
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT04882449 ↗Enrolled (actual)
329
Serious AEs
—
Results posted
Feb 2025
Primary outcome: Primary: Number of Usable Worsening HF Events as Adjudicated by CEC — 69 Adjudicated Events
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Bodyport Cardiac Scale (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bodyport Inc.
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Usable Worsening HF Events as Adjudicated by CEC |
69 | — |
Summary
The main goal of this study is to use data from the Bodyport Cardiac Scale to help detect of worsening heart failure (HF) early.
Eligibility Criteria
Inclusion Criteria
- Provide informed consent before trial enrollment
- Age ≥ 18 years
- A diagnosis of symptomatic HF including a worsening HF event in the preceding 12 months. Worsening HF events will be determined by local clinician-investigators and will typically include the following: a) HF symptoms (eg, dyspnea, fatigue); b) HF signs (eg, elevated jugular venous pressure, peripheral edema), or laboratory/imaging evidence of HF (eg, pulmonary congestion on chest x-ray, elevated natriuretic peptide levels) during the event, and treatments targeting acute HF (eg, intravenous diuretics, vasodilators, or inotropes).
Exclusion Criteria
- Weight >170 kg
- Use of chronic inotropic therapy
- Prior heart transplant or currently listed for heart transplant
- Current or planned left ventricular assistance device
- Chronic kidney disease requiring chronic dialysis
- Unknown left ventricular ejection fraction (LVEF). The LVEF should be based on the most recent local measurement using echocardiography, multigated acquisition scan, computed tomography scanning, magnetic resonance imaging, or ventricular angiography. Patients with preserved and reduced LVEF will be permitted in the study though enrollment may be capped to ensure no more than approximately 2/3 of the total enrollment includes patients with preserved or reduced LVEF.
- Terminal illness other than HF, such as malignancy, or with a life expectancy of less than 1 year as determined by the enrolling clinician-investigator
- Unable to participate in longitudinal follow-up including daily use of the Bodyport scale. Patients must be able to stand independently on the Bodyport scale.
Data sourced from ClinicalTrials.gov (NCT04882449). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.