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Surveillance and Alert-based Multiparameter Monitoring to Reduce Worsening Heart Failure Events - SCALE-HF1
The main goal of this study is to use data from the Bodyport Cardiac Scale to help detect of worsening heart failure (HF) early.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
RecioMed Clinical Research Network, Inc.
Boynton Beach, Florida, United States
Cardiovascular Institute of Northwest Florida
Panama City, Florida, United States
The Heart Center of Northeast Georgia Medical Center
Gainesville, Georgia, United States
University of Kansas School of Medicine
Kansas City, Kansas, 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
Self Regional Healthcare Research Center
Hodges, South Carolina, United States
Start Date
July 8, 2021
Primary Completion Date
April 30, 2023
Completion Date
July 31, 2023
Last Updated
February 10, 2025
329
ACTUAL participants
Bodyport Cardiac Scale
DEVICE
Lead Sponsor
Bodyport Inc.
Collaborators
NCT07484009
NCT07191730
Data Source & Attribution
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