Lasix for Heart Failure
(GatorScalesWHF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new method for managing worsening heart failure at home using a treatment called Lasix ONYU. Researchers seek to evaluate its effectiveness outside the hospital, its safety, and its ease of use for patients. They also aim to refine the process before it becomes standard practice. Suitable participants have experienced heart failure, struggle with fluid buildup that pills cannot control, and require at least three days of diuretic treatment to remove excess fluid. Participants should be able to use the Lasix ONYU device or have someone available to assist them. As a Phase 4 trial, this research focuses on understanding how this FDA-approved and effective treatment can benefit more patients.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What is the safety track record for Lasix ONYU?
Research shows that the FDA has approved Lasix ONYU to treat swelling from excess fluid in adults with chronic heart failure. This approval indicates it has been tested and found safe for this condition. Studies have shown that most patients generally tolerate it well.
However, like any treatment, side effects may occur. Common side effects of Lasix ONYU include dehydration, low blood pressure, or an imbalance of minerals in the body. These effects are typical for diuretics, which help the body remove extra fluid.
Since the trial is in a later phase, the treatment has already passed earlier safety checks. This phase focuses more on understanding how it works in everyday situations. While some risk exists with any treatment, existing data supports that Lasix ONYU is safe for most people when used as directed.12345Why are researchers enthusiastic about this study treatment?
Lasix ONYU is unique because it potentially offers a new take on how we manage heart failure. Most treatments for heart failure, like standard diuretics, help by removing excess fluid from the body. But Lasix ONYU may work differently, potentially providing more efficient fluid removal or improved patient outcomes. Researchers are excited because this could mean better symptom control and quality of life for patients living with heart failure.
What is the effectiveness track record for Lasix ONYU in treating heart failure?
Research has shown that Lasix ONYU, the treatment under study in this trial, effectively treats heart failure. Studies have found that the body absorbs Lasix ONYU as well as the intravenous (IV) version, with 112% bioavailability, meaning it works as effectively as the IV form. Designed for home use, Lasix ONYU provides a similar effect in removing excess fluid as traditional hospital treatment. The FDA has approved it, and experts believe it could transform heart failure care by making treatment more convenient at home.36789
Are You a Good Fit for This Trial?
This trial is for adults over 18 with worsening heart failure who have high BNP levels, significant jugular vein pressure, leg edema, recent weight gain due to fluid retention, and an S3 heart sound. They should have tried increasing their oral diuretic dose without success or be too advanced for such attempts.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive at-home decongestion treatment using Lasix ONYU for worsening heart failure
Follow-up
Participants are monitored for safety and effectiveness after treatment, including hospital readmission and adverse reactions
What Are the Treatments Tested in This Trial?
Interventions
- Lasix ONYU
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
SQ Innovation, Inc.
Industry Sponsor