Status:
COMPLETED
Surveillance and Alert-based Multiparameter Monitoring to Reduce Worsening Heart Failure Events
Lead Sponsor:
Bodyport Inc.
Collaborating Sponsors:
Duke Clinical Research Institute
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief 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.
Detailed Description
The overarching goal of this prospective, multicenter study is to utilize data from the Bodyport Cardiac Scale to develop an index that allows for the early detection of worsening heart failure (HF). ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 8 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
329 Patients enrolled
Trial Details
Trial ID
NCT04882449
Start Date
July 8 2021
End Date
July 31 2023
Last Update
February 10 2025
Active Locations (8)
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1
RecioMed Clinical Research Network, Inc.
Boynton Beach, Florida, United States, 33472
2
Cardiovascular Institute of Northwest Florida
Panama City, Florida, United States, 32405
3
The Heart Center of Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
4
University of Kansas School of Medicine
Kansas City, Kansas, United States, 66160