NCT06979726RecruitingPhase 4
Gator SCALES-WHF: SubCutaneous Administration of Lasix to Eliminate Symptoms of Worsening Heart Failure
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 13 May 2025
- Start date
- 20 Nov 2025
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- University of Florida
- Diseases
- Heart failure
- NCT number
- NCT06979726
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- From 20 Nov 2025 to the primary completion date, 30 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Age above 80 years
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.