Fluid Guided Heart Failure Treatment at the Cleveland Clinic

Last updated: November 7, 2025
Sponsor: Bodyport Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Congestive Heart Failure

Hyponatremia

Treatment

Heart Failure Management Intervention

Clinical Study ID

NCT07205120
25-529
  • Ages > 21
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Hospitalized for acute decompensated heart failure

  • Age 21 years or older

  • Able to speak and read English

Exclusion

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 todiuretic therapy or on chronic renal dialysis

  • Have a history of regularly scheduled intravenous HF therapy (e.g., inotropes ordiuretics)

  • 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 Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Heart Failure Management Intervention
Phase:
Study Start date:
October 08, 2025
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • The Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Active - Recruiting

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