drugset / Trial / NCT06979726

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

NCT06979726

Phase 4 Recruiting 100 enrolled University of Florida SQ Innovation, Inc. · collab
NaSingle-groupOpen-labelTreatment

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 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.

Timeline

Start
2025-11-20
Primary completion
2026-11-30
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Furosemide Other / unclassified Subcutaneous

Indications