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RecruitingNCT06979726GatorScalesWHFUpdated Jun 8, 2026

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

A Phase 4 interventional study of Lasix ONYU in Heart Failure and Volume Overload, sponsored by University of Florida. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-08.

Sponsored by University of Florida · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2025; still recruiting 11 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.
Read the detailed description

The investigators will conduct an open-label, non-comparative, real-world study to evaluate the effectiveness and feasibility of at-home decongestion treatment using Lasix ONYU in patients with worsening heart failure (WHF). During a clinical visit at the UF Heart Failure Clinic, Emergency Department, or Clinical Decision Unit, the study assess whether a patient meets eligibility criteria for the study.

02

Conditions studied

  • Heart Failure
  • Volume Overload
03

In context

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

This study's planned enrollment of 100 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.

Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.

Browse University of Florida studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18 or above
  2. Previously diagnosed with Congestive Heart Failure (HFpEF or HFrEF)

  3. Fluid overload due to worsening HF requiring parenteral diuretic treatment as assessed by at least 2 of the following:

    1. BNP > 200
    2. JVP > 10cmH20
    3. Presence of S3
    4. LE Edema
    5. Weight gain of > 5lbs in the past 5 days
  4. Failed oral uptitration of loop diuretic over the prior 5 days or presented with symptoms too advance to justify additional oral uptitration attempts to resolve congestion symptoms.
  5. Expected to require a minimum of three days of parenteral diuretic treatment
  6. Written
  7. Able and willing to operate Lasix ONYU and comply with study requirements or has a caregiver who can assume these roles.

Exclusion criteria

Exclusion Criteria:

  1. Age above 80 years
  2. Unable or unwilling to provide .
  3. Any medical condition or circumstances that would require further clinical investigation or hospitalization
  4. Presence or history of electrolyte abnormalities that may be exacerbated by parenteral loop diuretic treatment
  5. Home or current living environment not suitable for outpatient management and diuresis
  6. Pregnant or breastfeeding
  7. Unable to comply with clinic-required follow up procedure
  8. Baseline chronic renal disease with CKD Stage V
  9. Any surgical or medical condition which, in the opinion of the investigator, may pose an undue risk to the subject, interfere with participation in the study or which may affect the integrity of the data
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    Lasix ONYU

    Patients receiving Lasix ONYU

    Drug: Lasix ONYU

Interventions

  • DrugLasix ONYU

    Providing subcutaneous furosemide to eligible patients

06

What researchers measure

Primary outcomes

  1. Safety of Lasix ONYU Use

    Adverse reactions, acute kidney injury

    Time frame: 30 days

Secondary outcomes

  1. Hospital Readmission

    30 day readmission from time of Lasix ONYU administration

    Time frame: 30 days

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2025 (actual). Primary completion is estimated for Nov 2026, 12 months after the start.

Of 164 non-industry phase 4 interventional studies under Heart Failure, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 56. This study's planned 12 months is below that.

Counting every sponsor, half of 183 studies reached it within 31 months; a quarter within 22 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
May 13, 2025
First posted
May 20, 2025
StartActual
Nov 20, 2025
Primary completionEst.
Nov 30, 2026
CompletionEst.
Dec 31, 2026
Last update
Jun 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06979726
Lead sponsor
University of Florida
Collaborators
SQ Innovation, Inc.
Responsible party
Sponsor
First posted
May 20, 2025
Start date
Nov 20, 2025
Primary completion
Nov 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jun 8, 2026

Study contacts

Mustafa M Ahmed, MD
Contact
mustafa.ahmed@medicine.ufl.edu
352-273-9065

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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