Tests a home-use subcutaneous furosemide option for worsening heart failure
Tests Lasix ONYU given under the skin at home for people with worsening heart failure.
Plain-language title generated from the registry record
Registry title: Gator SCALES-WHF: SubCutaneous Administration of Lasix to Eliminate Symptoms of Worsening Heart Failure
Key facts
- Where
- Gainesville, United StatesSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06979726, who can take part
Where in United States
- University of FloridaGainesville, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Florida
- Trial code
- NCT06979726
- Record updated
- 8 June 2026
- Original description
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.Read full original descriptionShow less
Gator SCALES-WHF: SubCutaneous Administration of Lasix to Eliminate Symptoms of Worsening Heart Failure
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.
Inclusion: 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: 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; 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; Age above 80 years; Unable or unwilling to provide informed consent; Home or current living environment not suitable for outpatient management and diuresis; Pregnant or breastfeeding; Unable to comply with clinic-required follow up procedure.