Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Heart Failure
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: All subjects will be given the Bodyport scale to useMasking: None (Open Label)Masking Description: 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.Primary Purpose: Diagnostic

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 regula...

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.

Tracking Information

NCT #
NCT04882449
Collaborators
  • Bodyport Inc.
  • Duke Clinical Research Institute
Investigators
Principal Investigator: Adam Devore, MD Duke Clinical Research Institute