Gator SCALES-WHF: SubCutaneous Administration of Lasix to Eliminate Symptoms of Worsening Heart F… (NCT06979726) | Clinical Trial Compass
RecruitingPhase 4
Gator SCALES-WHF: SubCutaneous Administration of Lasix to Eliminate Symptoms of Worsening Heart Failure
United States100 participantsStarted 2025-11-20
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Age above 80 years
✕. Unable or unwilling to provide informed consent.
✕. Any medical condition or circumstances that would require further clinical investigation or hospitalization