Fluid-guided heart failure management using the Bodyport Cardiac Scale
Fluid Guided Heart Failure Treatment
This pilot will test whether a program using the Bodyport Cardiac Scale and a Congestion Index can help guide care for adults with acute or chronic heart failure followed at the Cleveland Clinic.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Bodyport Inc. Industry-sponsored |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT07205120 on ClinicalTrials.gov |
What this trial studies
FIGHT-HF is a non-randomized, open-label pilot enrolling 50 adults with acute or chronic heart failure who are followed by a Cleveland Clinic cardiologist. Participants will use the Bodyport Cardiac Scale and a composite Congestion Index to generate alerts that are processed through an Alert Response Guide (ARG). The study will integrate the scale and ARG into existing clinical workflows to see how the data perform in routine care and to refine management protocols. Results will inform potential future randomized trials of Congestion Index-guided heart failure management.
Who should consider this trial
Good fit: Adults age 21 or older hospitalized for acute decompensated heart failure or with chronic heart failure who are followed by a Cleveland Clinic cardiologist, can stand on two bare feet, and can read and speak English.
Not a fit: Patients unlikely to benefit include those with NYHA class IV symptoms, planned transplant or VAD, severe renal failure or dialysis dependence, regular IV heart-failure therapy, pregnancy, inability to stand unassisted, or weight over 375 lbs.
Why it matters
Potential benefit: If successful, this approach could help detect fluid congestion earlier and guide timely treatment changes to reduce symptoms and hospital visits.
How similar studies have performed: Implanted hemodynamic monitors and some remote monitoring programs have shown clinical benefit, but noninvasive scale-based congestion algorithms like this are newer and have limited prior outcome data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cleveland, Ohio
- The Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.