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

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Device: Bodyport Scale

• Registration Number: NCT04882449
• Lead Sponsor: Bodyport Inc.

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). The Bodyport Cardiac 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 Cardiac 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.

Study Timeline

• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-12
• Study Start: 2021-07-08
• Primary Completion: 2023-04-30
• Study Completion: 2023-07-31
• Results First Submitted: 2024-09-17
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Results First Posted: 2025-02-10
• Last Update Posted: 2025-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 329

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bodyport Scale	Bodyport Scale	All subjects will be given the Bodyport scale to use

Primary Outcome Measures

Name	Time	Method
Number of Usable Worsening HF Events as Adjudicated by CEC	Approximately 1 year	Worsening HF will be defined as a composite of the following: urgent, unscheduled clinic or emergency department visit or hospital admission with a primary diagnosis of HF in which the patient exhibited new or worsening symptoms of HF on presentation, had objective evidence of new or worsening HF, and received initiation or intensification of treatment for HF.

Trial Locations

Locations (8)

Self Regional Healthcare Research Center; 🇺🇸 Hodges, South Carolina, United States

Cardiovascular Institute of Northwest Florida; 🇺🇸 Panama City, Florida, United States

University of Kansas School of Medicine; 🇺🇸 Kansas City, Kansas, United States

RecioMed Clinical Research Network, Inc.; 🇺🇸 Boynton Beach, Florida, United States

The Heart Center of Northeast Georgia Medical Center; 🇺🇸 Gainesville, Georgia, 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