RecruitingPhase 4NCT06979726

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

Sponsor

University of Florida

Enrollment

100 participants

Start Date

Nov 20, 2025

Study Type

INTERVENTIONAL

Conditions

Heart Failure Volume Overload

Summary

The primary objective of the study is to develop, implement, and evaluate a site-specific clinical pathway for at-home treatment of eligible patients presenting to the clinic with worsening heart failure. The secondary objectives are: 1. To evaluate patient factors related to parenteral decongestion at home. 2. To evaluate the safety and device operation of Lasix ONYU treatment under circumstances that mimic real-world use. 3. To identify opportunities for process improvement before the routine implementation of the new clinical pathway.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria12

Age 18 or above
Previously diagnosed with Congestive Heart Failure (HFpEF or HFrEF)
Fluid overload due to worsening HF requiring parenteral diuretic treatment as assessed by at least 2 of the following:
BNP \> 200
JVP \> 10cmH20
Presence of S3
LE Edema
Weight gain of \> 5lbs in the past 5 days
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.
Expected to require a minimum of three days of parenteral diuretic treatment
Written informed consent
Able and willing to operate Lasix ONYU and comply with study requirements or has a caregiver who can assume these roles.

Exclusion Criteria9

Age above 80 years
Unable or unwilling to provide informed consent.
Any medical condition or circumstances that would require further clinical investigation or hospitalization
Presence or history of electrolyte abnormalities that may be exacerbated by parenteral loop diuretic treatment
Home or current living environment not suitable for outpatient management and diuresis
Pregnant or breastfeeding
Unable to comply with clinic-required follow up procedure
Baseline chronic renal disease with CKD Stage V
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