Gator SCALES-WHF: SubCutaneous Administration of Lasix to Eliminate Symptoms of Worsening Heart Failure
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Florida
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 or above
Previously diagnosed with Congestive Heart Failure (HFpEF or HFrEF)
BNP > 200
JVP > 10cmH20
Disqualifiers
Age above 80 years
Unable or unwilling to provide informed consent.
Any medical condition or circumstances that would require further clinical investigation or hospitalization
Presence or history of electrolyte abnormalities that may be exacerbated by parenteral loop diuretic treatment
Trial design
Design model
Single group
Treatments tested in this trial
Lasix ONYU
DrugProviding subcutaneous furosemide to eligible patients
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Lasix ONYUOther 1 intervention
Trial outcomes
Primary outcomes
1
Safety of Lasix ONYU Use
Adverse reactions, acute kidney injury
Time frame
30 daysSecondary outcomes
1
Hospital Readmission
30 day readmission from time of Lasix ONYU administration
Time frame
30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Florida
Lead sponsor
SQ Innovation, Inc.
Collaborator
Source ClinicalTrials.gov