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CompletedNCT04975633Updated Feb 26, 2025

USC and Bodyport Remote Heart Failure Management Study

An interventional study of Bodyport Cardiac Scale in Heart Failure, sponsored by University of Southern California. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-26.

Sponsored by University of Southern California · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was Sep 2024, 2 years 1 month ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

A feasibility study investigating the Bodyport virtual cardiac clinic vs usual care for outpatient heart failure management at Keck Medical Center of USC

Read the detailed description

Heart failure is a debilitating disease associated with high hospitalization rates which could potentially be curbed by remote patient monitoring. Remote monitoring may allow for the early detection of signs and symptoms of cardiac decompensation, enabling prompt interventions to reduce hospital admission rates or the duration of inpatient stay, and the quality of life of those suffering from heart failure. Recent studies have demonstrated that structured remote patient management interventions can reduce the percentage of days lost to unplanned cardiovascular admissions. The investigators propose assessing the feasibility of a structured virtual cardiac care service leveraging the Bodyport platform to optimize outpatient management of heart failure.

This study will leverage the Bodyport virtual cardiac clinic platform to deliver care for the heart failure patient population at Keck Medical Center of USC. Patients randomized to the intervention arm will receive the Bodyport Cardiac Scale for home monitoring as well as heart failure education and non-clinical support from Bodyport coaches. Daily measurement uploads from the patients will be analyzed and changes in measurement data will be used to guide follow-up and care management, such as diuretic dose adjustments. For this initial feasibility study, the investigators will be focusing on patient and provider satisfaction of the virtual cardiac clinic along with the operational ease of executing this form of care compared to standard care.

02

Conditions studied

  • Heart Failure

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 39 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.

Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of HFrEF or HFpEF and hospital discharge for a heart failure exacerbation within 14 days of enrollment.
  • 18 years of age or older
  • English speaking
  • Able to safely stand on the Bodyport scale
  • Patients must have a reliable and working phone for communication with the care team
  • All patients should have access to the internet via a computer or mobile device to access the Bodyport care platform
  • Patients must have a safe and secure place to store the Bodyport device

Exclusion criteria

Exclusion Criteria:

  • Weight >375 lbs.
  • History of repeatedly missing follow-up appointments or being unreachable by phone
  • Inability to stand on the Bodyport scale for the duration needed to capture data
  • Patient in jail or currently homeless
  • Known or documented noncompliance with medical therapy
  • Unable to speak English
  • Unable or unwilling to answer survey questions
  • History of heart transplantation
  • Chronic kidney disease stage IV or V and/or on hemodialysis
  • Presence of a ventricular assist device
  • Presence of a CardioMEMs pulmonary artery sensor
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    BodyPort Cardiac Scale

    Patient will receive the Bodyport scale with access to Bodyport care services, such as remote monitoring, educational materials, different biomarkers detected by the scale, and online access to their data

    Device: Bodyport Cardiac Scale

  • No intervention
    Control

    Patients will receive usual care and a Bodyport scale that only displays weight and weight change. No other access to care services, features, or materials will be provided during this 90 day period

Interventions

  • DeviceBodyport Cardiac Scale

    Patients will be instructed to take daily measurements for 90 days. Data will be transmitted to Bodyport and concerning findings (weight gain, change of impedance, elevated heart rate) will be reported back to the medical team. The medical team will either choose to act on the information given or continue to observe trends. Interventions may include titration of therapy, change in therapy, fluid restriction, sodium restriction and lifestyle modification

06

What researchers measure

Primary outcomes

  1. Change in quality of life

    Evaluating Kansas City Cardiomyopathy Questionnaire (KCCQ) measurements at the time of hospital discharge and 90-days post-discharge

    Time frame: Up to 14 days after enrollment and approximately 90-days post-enrollment

  2. Scale Adherence

    Measure of daily scale adherence

    Time frame: Through study completion, approximately 90 days

Secondary outcomes

  1. Patient and provider satisfaction

    Assessing patient and provider satisfaction with the Bodyport virtual cardiac clinic at USC Keck Medicine through semi-structured interviews

    Time frame: Through study completion, approximately 90 days for patients and an average of 9 months for providers.

07

Study locations

1 site
  • Keck Medical Center of USC
    Los Angeles, California 90033, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04975633
Lead sponsor
University of Southern California
Responsible party
Michael William Fong (Associate Professor of Clinical Medicine, University of Southern California) — Principal investigator
First posted
Jul 23, 2021
Start date
May 10, 2021
Primary completion
Sep 5, 2024
Completion
Sep 5, 2024
Last update
Feb 26, 2025

Study contacts

Michael W Fong, MD
principal investigator · Keck Medical Center of USC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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