Fluid Guided Heart Failure Treatment at the Cleveland Clinic
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorBodyport Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Hospitalized for acute decompensated heart failure
Age 21 years or older
Able to speak and read English
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Heart Failure Management Intervention
DeviceParticipants 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Interventional armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Congestion Index Alert Statistics
Time frame
From enrollment to the end of the study duration at 90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov