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NCT07205120NARecruiting

Fluid Guided Heart Failure Treatment at the Cleveland Clinic

Bodyport Inc.

Start Date

10/8/2025

Completion Date

3/1/2026

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.

Detailed Description

This study will assess the clinical integration of the Cardiac Scale and a composite biomarker algorithm, the Congestion Index and Alert, into existing health system workflows for HF management. The data collected in this study will be used to test and refine existing Congestion Index-guided HF management protocols contained within an Alert Response Guide (ARG). The final Alert Response Guide may be further validated in future randomized control trials.

Eligibility Criteria

Age Range: 21 years to No maximum

Inclusion Criteria: * Hospitalized for acute decompensated heart failure * Age 21 years or older * Able to speak and read English Exclusion Criteria: * 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

DEVICE

Heart Failure Management Intervention

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Conditions

Heart Failure

Locations

The Cleveland Clinic

Cleveland, Ohio 44195

United States