NCT04882449

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

Surveillance and Alert-based Multiparameter Monitoring to Reduce Worsening Heart Failure Events - SCALE-HF1

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 329 (actual)
• Sponsor: Bodyport Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Bodyport Cardiac Scale	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.

Timeline

• Start date: 2021-07-08
• Primary completion: 2023-04-30
• Completion: 2023-07-31
• First posted: 2021-05-12
• Last updated: 2025-02-10
• Results posted: 2025-02-10

Locations

8 sites across 1 country: United States