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Clinical Trial NCT07205120 (FIGHT-HF) for Heart Failure is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Fluid Guided Heart Failure Treatment at the Cleveland Clinic (FIGHT-HF) 50 Randomized Open-Label

Recruiting
Clinical Trial NCT07205120 (FIGHT-HF) is an interventional study for Heart Failure that is recruiting. It started on 8 October 2025 with plans to enroll 50 participants. Led by Bodyport Inc., it is expected to complete by 1 March 2026. The latest data from ClinicalTrials.gov was last updated on 12 November 2025.
Brief 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...Show More
Official Title

Fluid Guided Heart Failure Treatment

Conditions
Heart Failure
Other Study IDs
  • FIGHT-HF
  • 25-529
NCT ID Number
NCT07205120
Start Date (Actual)
2025-10-08
Last Update Posted
2025-11-12
Completion Date (Estimated)
2026-03
Enrollment (Estimated)
50
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
scale
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalInterventional 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. ...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Congestion Index Alert Statistics
From enrollment to the end of the study duration at 90 days
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
21 Years
Eligible Sexes
All
  • Hospitalized for acute decompensated heart failure
  • Age 21 years or older
  • Able to speak and read English

  • 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
Bodyport Inc. logoBodyport Inc.
No contact data.
1 Study Locations in 1 Countries

Ohio

The Cleveland Clinic, Cleveland, Ohio, 44195, United States
Elaine Franko, Contact, 216-444-9020, [email protected]
Recruiting