Fluid Guided Heart Failure Treatment at the Cleveland Clinic (FIGHT-HF)

Bodyport

Status: Enrolling

Conditions: Heart Failure

Treatments: Device: Heart Failure Management Intervention

Study type: Interventional

Funder types: Industry

Identifiers

NCT07205120

25-529

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Interventional arm

Experimental group

Description:

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.

Treatment:

Device: Heart Failure Management Intervention