Actively Recruiting
Gator SCALES-WHF: SubCutaneous Administration of Lasix to Eliminate Symptoms of Worsening Heart Failure
Led by University of Florida · Updated on 2025-11-24
100
Participants Needed
1
Research Sites
23 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
S
SQ Innovation, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gator SCALES-WHF: SubCutaneous Administration of Lasix to Eliminate Symptoms of Worsening Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or above
- Previously diagnosed with Congestive Heart Failure (HFpEF or HFrEF)
- Fluid overload due to worsening heart failure requiring parenteral diuretic treatment as shown by at least 2 of the following: BNP > 200, JVP > 10cmH20, presence of S3, lower extremity edema, or weight gain of > 5lbs in past 5 days
- Failed oral uptitration of loop diuretic over prior 5 days or have symptoms too advanced for oral treatment
- Expected to need at least three days of parenteral diuretic treatment
- Provided written informed consent
- Able and willing to operate Lasix ONYU and comply with study requirements or has a caregiver who can do so
You will not qualify if you...
- Age above 80 years
- Unable or unwilling to provide informed consent
- Medical conditions or circumstances requiring further clinical investigation or hospitalization
- History or presence of electrolyte abnormalities that could worsen with parenteral loop diuretics
- Home or living environment unsuitable for outpatient management and diuresis
- Pregnant or breastfeeding
- Unable to comply with required clinic follow-up
- Baseline chronic kidney disease Stage V
- Any surgical or medical condition posing undue risk or interfering with study participation or data integrity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
Research Team
M
Mustafa M Ahmed, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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