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Gator SCALES-WHF: SubCutaneous Administration of Lasix to Eliminate Symptoms of Worsening Heart Failure

Study acronym: GatorScalesWHF
StatusRecruiting
PhasePhase 4
Started2025-11-20
View on ClinicalTrials.gov ↗

Amendment history

2026-06-03
Study Status v2
Primary completion date2026-03-31→2026-11-30
Completion date2026-05-01→2026-12-31
2025-11-19
Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Study Description, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-12-31→2026-03-31
Completion date2026-01-31→2026-05-01
Start dateestimated 2025-07-01→confirmed 2025-11-20
Study sites0→1
Study description+17 characters
WeThe investigators will conduct an open-label, non-comparative, real-world stu [...] re Clinic, Emergency Department, or Clinical Decision Unit, wethe willstudy assess whether a patient meets eligibility criteria for the study.
2025-05-13
Original filing
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.
Trial Details
NCT Number NCT06979726
Lead Sponsor University of Florida
Collaborators: SQ Innovation, Inc.
Conditions Heart Failure, Volume Overload
Enrollment 100 participants
Start Date 2025-11-20
Primary Completion 2026-11-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-08