RecruitingNot ApplicableNCT07205120

Fluid Guided Heart Failure Treatment at the Cleveland Clinic

Fluid Guided Heart Failure Treatment

Sponsor

Bodyport Inc.

Enrollment

50 participants

Start Date

Oct 8, 2025

Study Type

INTERVENTIONAL

Conditions

Heart Failure

Summary

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.

Eligibility

Min Age: 21 Years

Inclusion Criteria3

Hospitalized for acute decompensated heart failure
Age 21 years or older
Able to speak and read English

Exclusion Criteria8

New York Heart Association functional class IV symptoms
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

Interventions

DEVICEHeart 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.