NCT07205120

Fluid Guided Heart Failure Treatment at the Cleveland Clinic

Fluid Guided Heart Failure Treatment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Bodyport Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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 in future randomized control trials.

Conditions

• Heart Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-08
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2025-10-03
• Last updated: 2025-11-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study