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

Sponsor
Bodyport Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04882449
Collaborator
Duke Clinical Research Institute (Other)
300
Enrollment
8
Locations
1
Arm
17.8
Anticipated Duration (Months)
37.5
Patients Per Site
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Bodyport Scale
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
All subjects will be given the Bodyport scale to useAll subjects will be given the Bodyport scale to use
Masking:
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
Official Title:
Surveillance and Alert-based Multiparameter Monitoring to Reduce Worsening Heart Failure Events - SCALE-HF 1
Actual Study Start Date :
Jul 8, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bodyport Scale

All subjects will be given the Bodyport scale to use

Device: Bodyport Scale
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.
Other Names:
  • Bodyport, Inc

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Worsening HF Events as measured by patient report [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.

    Secondary Outcome Measures

    1. Number of patients that had an urgent care visit with the primary diagnosis of HF as measured by medical record abstraction. [Approximately 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 RecioMed Clinical Research Network, Inc. Boynton Beach Florida United States 33472
    2 Cardiovascular Institute of Northwest Florida Panama City Florida United States 32405
    3 The Heart Center of Northeast Georgia Medical Center Gainesville Georgia United States 30501
    4 University of Kansas School of Medicine Kansas City Kansas United States 66160
    5 Wayne State University Detroit Michigan United States 48201
    6 Duke University Medical Center Durham North Carolina United States 27710
    7 Temple University - Lewis Katz School of Medicine Philadelphia Pennsylvania United States 19140
    8 Self Regional Healthcare Research Center Hodges South Carolina United States 29653

    Sponsors and Collaborators

    • Bodyport Inc.
    • Duke Clinical Research Institute

    Investigators

    • Principal Investigator: Adam Devore, MD, Duke Clinical Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Bodyport Inc.
    ClinicalTrials.gov Identifier:
    NCT04882449
    Other Study ID Numbers:
    • Pro00107534
    First Posted:
    May 12, 2021
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Bodyport Inc.
    Bodyport
    Heart Failure
    Decompensation
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Jul 20, 2022