Fluid Guided Heart Failure Treatment at the Cleveland Clinic

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Bodyport Inc.
Study ID
NCT07205120
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Heart Failure Management Intervention — DEVICE
    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.

Study Details

FIGHT-HF is an exploratory non-randomized open-label study evaluating a heart failure management intervention. 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.

Key Dates

Start date
Oct 8, 2025
Status verified
Nov 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Congestion Index Alert Statistics [ Time Frame: From enrollment to the end of the study duration at 90 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Cleveland ClinicClevelandOhio44195
Elaine Franko
[email protected]
216-444-9020

Find similar trials in Cleveland, OH

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
The Cleveland Clinic· Cleveland, OH

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