Fluid Guided Management for Heart Failure
(FIGHT-HF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to manage heart failure using a special scale at home to guide fluid levels and treatment. The goal is to evaluate its effectiveness for individuals with both acute (sudden) and chronic (long-term) heart failure. Participants will undergo monitoring and follow-up visits to assess their health and any medication changes. This trial may suit those hospitalized for heart failure who follow up with a Cleveland Clinic cardiologist. As an unphased trial, it offers a unique opportunity to contribute to innovative heart failure management research.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this heart failure management intervention is safe?
Research has shown that managing body fluids can help people with heart failure by keeping fluid levels balanced and reducing stress on the heart. Although specific safety data for this program is not yet available, fluid management is generally safe and commonly used in treating heart failure.
This trial is in an early stage, often used for exploratory studies, meaning it is still in the initial phases of testing. As a result, detailed safety information might not be fully available. However, fluid management is a regular part of heart failure treatment and is usually well-tolerated. Researchers will closely monitor participants to ensure their safety.12345Why are researchers excited about this trial?
Researchers are excited about the Fluid Guided Management for Heart Failure because it introduces a new way of managing fluid levels in patients' bodies directly at home. Unlike traditional methods that often rely on hospital visits for adjustments, this approach uses a device that allows patients to monitor and manage their fluid levels themselves in an outpatient setting. This method could lead to more personalized and immediate adjustments in care, potentially reducing hospital readmissions and improving overall patient outcomes.
What evidence suggests that this fluid-guided heart failure management intervention is effective for heart failure?
Research has shown that managing fluid levels is crucial for people with heart failure. Studies have found that monitoring and adjusting these levels can help prevent fluid overload, a common issue in heart failure. For instance, using blood volume analysis (BVA), patients have experienced better outcomes, such as fewer hospital visits and improved symptoms. In this trial, participants in the interventional arm will receive fluid-guided care using a device in the outpatient (home) setting. The Cleveland Clinic is testing this approach, aiming to use a fluid-guided management program to help patients manage their heart failure more effectively. Early results suggest that this strategy could lead to better control of symptoms and overall heart health.678910
Are You a Good Fit for This Trial?
This trial is for adults with acute or chronic heart failure who are under the care of a Cleveland Clinic cardiologist. It's not suitable for people who don't meet specific health criteria set by the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants begin receiving fluid-guided care using the Bodyport Cardiac Scale and Congestion Index in the outpatient setting
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits to assess clinical status, events, and medication changes
What Are the Treatments Tested in This Trial?
Interventions
- Heart Failure Management Intervention
Trial Overview
The FIGHT-HF study is testing a fluid-guided heart failure management program using innovative technology like the Bodyport Cardiac Scale and Congestion Index to monitor patients' condition.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bodyport Inc.
Lead Sponsor
Citations
Fluid Management in Patients with Chronic Heart Failure
Congestion, or fluid overload, is a classic clinical feature of patients presenting with heart failure patients, and its presence is associated with adverse ...
Fluid Guided Heart Failure Treatment at the Cleveland Clinic
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 ...
Heart Failure Outcomes With Volume-Guided Management
BVA = blood volume analysis; CHF = congestive heart failure; HF = heart failure. ∗. Available CMS data for 2007 to 2009 were limited to one- ...
New Randomized Controlled Trial Demonstrates the ...
New Randomized Controlled Trial Demonstrates the Efficacy of Daxor's BVA Guided-Care in Heart Failure Patients. Data From Study Funded by NIH ...
Heart failure management guided by remote ...
Several implant-based remote monitoring strategies are currently tested to optimize heart failure (HF) management by anticipating clinical ...
Fluid Restriction for Patients with Heart Failure - PubMed Central
Fluid restriction has long been believed to benefit patients with heart failure by counteracting the activated renin–angiotensin aldosterone system and ...
Fluid Guided Management for Heart Failure (FIGHT-HF Trial)
FIGHT-HF is an exploratory non-randomized open-label study evaluating a heart failure management intervention.
2022 AHA/ACC/HFSA Guideline for the Management of ...
The recommendations present an evidence-based approach to managing patients with heart failure, with the intent to improve quality of care and ...
A Protocol for a Systematic Review and Meta-Analysis ...
Biomarker-Guided Versus Clinically Guided Fluid Management in Heart Failure: A Protocol for a Systematic Review and Meta-Analysis (Preprint).
Role of CVP to Guide Fluid Therapy in Chronic Heart Failure
The authors used the initial and subsequent change in CVP to guide fluid administration before elective coronary angiography in heart failure ( ...
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