Gator SCALES-WHF: SubCutaneous Administration of Lasix to Eliminate Symptoms of Worsening Heart Failure

Launched by UNIVERSITY OF FLORIDA · May 13, 2025

Keywords

ClinConnect Summary

The Gator SCALES-WHF clinical trial is studying a new way to treat patients with worsening heart failure at home. Heart failure can cause a buildup of fluid in the body, leading to uncomfortable symptoms. This trial will test a treatment using a device called Lasix ONYU, which delivers medication under the skin to help reduce this fluid overload. The goal is to create a safe and effective plan for managing this treatment at home, so patients can feel better without needing to stay in the hospital.

To be eligible for this trial, participants must be 18 years or older and have been diagnosed with heart failure. They should also have symptoms that indicate they need extra help with fluid management, which may include weight gain, swelling in the legs, or specific test results. Participants can expect to receive the Lasix treatment for at least three days and will need to use the device according to the study's guidelines. It's important to note that this trial is not yet recruiting participants, but it aims to ensure that the new treatment plan is safe and effective before it becomes widely available.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 or above
• • 2. Previously diagnosed with Congestive Heart Failure (HFpEF or HFrEF)
• 3. Fluid overload due to worsening HF requiring parenteral diuretic treatment as assessed by at least 2 of the following:
• • 1. BNP \> 200
• • 2. JVP \> 10cmH20
• • 3. Presence of S3
• • 4. LE Edema
• • 5. Weight gain of \> 5lbs in the past 5 days
• • 4. Failed oral uptitration of loop diuretic over the prior 5 days or presented with symptoms too advance to justify additional oral uptitration attempts to resolve congestion symptoms.
• • 5. Expected to require a minimum of three days of parenteral diuretic treatment
• • 6. Written informed consent
• • 7. Able and willing to operate Lasix ONYU and comply with study requirements or has a caregiver who can assume these roles.
• Exclusion Criteria:
• • 1. Age above 80 years
• • 2. Unable or unwilling to provide informed consent.
• • 3. Any medical condition or circumstances that would require further clinical investigation or hospitalization
• • 4. Presence or history of electrolyte abnormalities that may be exacerbated by parenteral loop diuretic treatment
• • 5. Home or current living environment not suitable for outpatient management and diuresis
• • 6. Pregnant or breastfeeding
• • 7. Unable to comply with clinic-required follow up procedure
• • 8. Baseline chronic renal disease with CKD Stage V
• • 9. Any surgical or medical condition which, in the opinion of the investigator, may pose an undue risk to the subject, interfere with participation in the study or which may affect the integrity of the data