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

November 7, 2025 updated by: Bodyport Inc.

Fluid Guided Heart Failure Treatment

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • The Cleveland Clinic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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. 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bodyport Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

September 24, 2025

First Submitted That Met QC Criteria

October 1, 2025

First Posted (Estimated)

October 3, 2025

Study Record Updates

Last Update Posted (Actual)

November 12, 2025

Last Update Submitted That Met QC Criteria

November 7, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-529

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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