Status:
RECRUITING
Gator SCALES-WHF: SubCutaneous Administration of Lasix to Eliminate Symptoms of Worsening Heart Failure
Lead Sponsor:
University of Florida
Collaborating Sponsors:
SQ Innovation, Inc.
Conditions:
Heart Failure
Volume Overload
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 fail...
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 worsen...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
November 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06979726
Start Date
November 20 2025
End Date
May 1 2026
Last Update
November 24 2025
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32608