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NCT Number: NCT07205120

Fluid Guided Heart Failure Treatment at the Cleveland Clinic

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

Elaine Franko

CONTACT

[email protected]

216-444-9020

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heart Failure Management Intervention

Device

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.

Primary outcomes

  1. Congestion Index Alert Statistics

    Time frame: From enrollment to the end of the study duration at 90 days

Sponsors and collaborators

Lead sponsor

Bodyport Inc.

Industry

Registry information

Official study title

Fluid Guided Heart Failure Treatment

Acronym: FIGHT-HF

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 3, 2025
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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