Recruiting

Heart Failure Management

Sponsor:

Bodyport Inc.

Code:

NCT07205120

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Heart Failure Management Intervention

Study Details

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

Study ID

NCT07205120

Start date

Oct 8, 2025

Status verified date

Nov, 2025

Completion date

Mar, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Congestion Index Alert Statistics [ Time Frame: From enrollment to the end of the study duration at 90 days ]

Central Contacts and Locations

Locations

The Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Elaine Franko

216-444-9020FRANKOE@ccf.org

More Information

Sponsor

Bodyport Inc.

Last update posted

Nov 12, 2025

Last verified

Nov, 2025

Keywords

  • scale

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bodyport Inc. on 2025-11-12.