Mode
Text Size
Log in / Sign up
N/A N=329

Surveillance and Alert-based Multiparameter Monitoring to Reduce Worsening Heart Failure Events

Heart Failure

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

Back to search