Fluid Guided Heart Failure Treatment at the Cleveland Clinic
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Heart Failure Management Intervention.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Fluid Guided Heart Failure Treatment
Overview
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.
Interventions
- 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 an
Primary outcome measures
- Congestion Index Alert Statistics [Time frame: From enrollment to the end of the study duration at 90 days]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The Cleveland Clinic — Cleveland
Identifiers
NCT: NCT07205120 · 25-529