Back to Trials
NCT06979726PHASE4Recruiting

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

University of Florida

Start Date

11/20/2025

Completion Date

12/31/2026

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.

Detailed Description

The investigators will conduct an open-label, non-comparative, real-world study to evaluate the effectiveness and feasibility of at-home decongestion treatment using Lasix ONYU in patients with worsening heart failure (WHF). During a clinical visit at the UF Heart Failure Clinic, Emergency Department, or Clinical Decision Unit, the study assess whether a patient meets eligibility criteria for the study.

Eligibility Criteria

Age Range: 18 years to 80 years

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

Interventions

DRUG

Lasix ONYU

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Heart FailureVolume Overload

Locations

University of Florida

Gainesville, Florida 32608

United States