Gator SCALES-WHF: SubCutaneous Administration of Lasix to Eliminate Symptoms of Worsening Heart Failure
Part of paid clinical trials in Gainesville, Florida.
- Sponsor
- University of Florida
- Study ID
- NCT06979726
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Heart Failure
- Volume Overload
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Lasix ONYU — DRUGProviding subcutaneous furosemide to eligible patients
Study Details
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.
Key Dates
- Start date
- Nov 20, 2025
- Status verified
- Jun 2026
- Primary completion
- Nov 30, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Other: Lasix ONYUPatients receiving Lasix ONYU
Primary Outcome Measure
Safety of Lasix ONYU Use [ Time Frame: 30 days ]
Central Contacts
- Mustafa M Ahmed, MD352-273-9065
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32608 | Mustafa Ahmed, MD |
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