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

Completed

Conditions studied: Heart Failure

In brief

The main goal of this study is to use data from the Bodyport Cardiac Scale to help detect of worsening heart failure (HF) early.

Key facts

Study ID

NCT04882449

Run by

Bodyport Inc.

People needed

329

Starts

2021-07-08

Expected to finish

2023-07-31

Last updated by the study team

2025-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• RecioMed Clinical Research Network, Inc. — Boynton Beach, Florida, United States
• Cardiovascular Institute of Northwest Florida — Panama City, Florida, United States
• The Heart Center of Northeast Georgia Medical Center — Gainesville, Georgia, United States
• University of Kansas School of Medicine — Kansas City, Kansas, United States
• Wayne State University — Detroit, Michigan, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Temple University - Lewis Katz School of Medicine — Philadelphia, Pennsylvania, United States
• Self Regional Healthcare Research Center — Hodges, South Carolina, United States

Full record on ClinicalTrials.gov

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