Surveillance and Alert-based Multiparameter Monitoring to Reduce Worsening Heart Failure Events (SCALE-HF 1)

Bodyport

Status: Active, not recruiting

Conditions: Heart Failure

Treatments: Device: Bodyport Scale

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04882449

Pro00107534

Details and patient eligibility

About

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

Full description

The overarching goal of this prospective, multicenter study is to utilize data from the Bodyport scale to develop an index that allows for the early detection of worsening heart failure (HF). The Bodyport scale is capable of measuring key HF parameters of congestion and cardiac perfusion on a regular basis in a patient's home. These data will be combined into a composite index that may be used to identify patients at increased risk for decompensation, inform the reason for their decline, and offer the possibility to remotely optimize therapy to prevent further worsening HF.

The SCALE-HF program will consist of multiple phases. For SCALE-HF 1, patients will be prospectively enrolled and utilize the Bodyport scale on a daily basis. Patients and clinicians will be blinded to the results other than data readily available from other devices such as body weight. There will be no attempt to influence clinical practice. Patients will be followed remotely for suspected clinical events.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provide informed consent before trial enrollment
2. Age ≥ 18 years
3. 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

1. Weight >170 kg
2. Use of chronic inotropic therapy
3. Prior heart transplant or currently listed for heart transplant
4. Current or planned left ventricular assistance device
5. Chronic kidney disease requiring chronic dialysis
6. 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.
7. 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
8. 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Bodyport Scale

Experimental group

Description:

All subjects will be given the Bodyport scale to use

Treatment:

Device: Bodyport Scale