Fluid Guided Heart Failure Treatment at the Cleveland Clinic

NCT07205120 | Recruiting FDA Device

• 1 other identifier: 25-529
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

scale

Outcome Measures

Primary Outcomes (1)

• Congestion Index Alert Statistics

  From enrollment to the end of the study duration at 90 days

Study Arms (1)

Interventional arm

EXPERIMENTAL

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

Interventions

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.

Interventional arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized for acute decompensated heart failure
• Age 21 years or older
• Able to speak and read English

You may not qualify if:

• 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

Sponsors & Collaborators

• Bodyport Inc.: lead

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 3, 2025
• Study Start: October 8, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)