Fluid Guided Heart Failure Treatment at the Cleveland Clinic
NCT ID: NCT07205120
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-10-08
2026-03-31
Brief Summary
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The goal of this pilot is to assess the performance of a fluid-guided heart failure management program and Alert Response Guide (ARG) using the Bodyport Cardiac Scale and Congestion Index in 50 adult participants with acute and chronic heart failure, who are followed by a Cleveland Clinic cardiologist.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Interventional arm
Participants will begin receiving fluid-guided care when they begin using the device in the outpatient (home) setting.
Participants will be monitored per routine clinical care and receive study follow-up visits at 45- and 90-days to assess clinical status, events, and medication changes.
Heart Failure Management Intervention
Participants will receive access to their weight and fluid levels on the Cardiac Scale and through the Bodyport Patient Portal. The provider will receive access to the Congestion Index, alerts, and Clinical Dashboard to support the remote management of the participant. The provider will receive a notice when an alert is generated and twice weekly reminders until the Congestion Index returns below an alert threshold. When an alert is generated, providers will attempt to contact the participant and will be encouraged to follow the recommendations contained within the ARG. Providers will also be encouraged to provide feedback and suggest improvements to the ARG throughout the study. Any changes to medical therapy resulting from an alert will be documented in the Bodyport Clinical Dashboard.
Interventions
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Heart Failure Management Intervention
Participants will receive access to their weight and fluid levels on the Cardiac Scale and through the Bodyport Patient Portal. The provider will receive access to the Congestion Index, alerts, and Clinical Dashboard to support the remote management of the participant. The provider will receive a notice when an alert is generated and twice weekly reminders until the Congestion Index returns below an alert threshold. When an alert is generated, providers will attempt to contact the participant and will be encouraged to follow the recommendations contained within the ARG. Providers will also be encouraged to provide feedback and suggest improvements to the ARG throughout the study. Any changes to medical therapy resulting from an alert will be documented in the Bodyport Clinical Dashboard.
Eligibility Criteria
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Inclusion Criteria
* Age 21 years or older
* Able to speak and read English
Exclusion Criteria
* Received or are scheduled to receive a heart transplant or ventricular assist - device in the next 12 months
* Have a glomerular filtration rate of less than 25 mL/min while nonresponsive to diuretic therapy or on chronic renal dialysis
* Have a history of regularly scheduled intravenous HF therapy (e.g., inotropes or diuretics)
* Have a life expectancy of less than 12 months
* Are pregnant or plan to become pregnant during the next 12 months
* Weigh greater than 375 lbs
* Unable to stand on two bare feet without assistance
21 Years
ALL
No
Sponsors
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Bodyport Inc.
INDUSTRY
Responsible Party
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Locations
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The Cleveland Clinic
Cleveland, Ohio, United States
Countries
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Facility Contacts
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Elaine Franko
Role: primary
Other Identifiers
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25-529
Identifier Type: -
Identifier Source: org_study_id