CompletedNot Applicable

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

United States329 participantsStarted 2021-07-08

Plain-language 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.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).

✕. 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.

Number of Usable Worsening HF Events as Adjudicated by CEC

Timeframe: Approximately 1 year

NCT IDNCT04882449

SponsorBodyport Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-04-30

Results submitted2024-09-17

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).

✕. 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.