Heart FailurePhase 4GatorScalesWHFNCT06979726
Gator SCALES-WHF: SubCutaneous Administration of Lasix to Eliminate Symptoms of Worsening Heart Failure
A Phase 4 study testing Lasix ONYU in people with Heart Failure and Volume Overload, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure, Volume Overload
- What is being tested?
- Lasix ONYU
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2025to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- LE Edema
- Weight gain of > 5lbs in the past 5 days
- 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.
- Expected to require a minimum of three days of parenteral diuretic treatment
- Written informed consent
- Able and willing to operate Lasix ONYU and comply with study requirements or has a caregiver who can assume these roles.
Who cannot join
- 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
- Home or current living environment not suitable for outpatient management and diuresis
- Pregnant or breastfeeding
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- Unable to comply with clinic-required follow up procedure
- Baseline chronic renal disease with CKD Stage V
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32608
Mustafa Ahmed, MD
About this study
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:
- To evaluate patient factors related to parenteral decongestion at home.
- To evaluate the safety and device operation of Lasix ONYU treatment under circumstances that mimic real-world use.
- 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.
- Conditions
- Heart Failure, Volume Overload
- Being tested
- Lasix ONYU
- Medical subject headings
- Heart Failure, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lasix ONYUDrug
Providing subcutaneous furosemide to eligible patients
| Study group | Role | What they receive |
|---|---|---|
| Lasix ONYU | Other | Patients receiving Lasix ONYU Receives: Drug: Lasix ONYU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Lasix ONYU Use
Adverse reactions, acute kidney injury
Measured: 30 days
Secondary outcomes (1)
Hospital Readmission
30 day readmission from time of Lasix ONYU administration
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start20 Nov 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- SQ Innovation, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979726
- Sponsor's protocol ID
- IRB202500547
- Acronym
- GatorScalesWHF
- Status last verified
- Jun 2026
- First submitted
- 13 May 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gator SCALES-WHF: SubCutaneous Administration of Lasix to Eliminate Symptoms of Worsening Heart Failure
- ClinicalTrials.gov ID
- NCT06979726
- Acronym / sponsor ID
- GatorScalesWHF / IRB202500547
- Conditions
- Heart Failure, Volume Overload
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- SQ Innovation, Inc.
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate patient factors related to parenteral decongestion at home.
- To evaluate the safety and device operation of Lasix ONYU treatment under circumstances that mimic real-world use.
- To identify opportunities for process improvement before the routine implementation of the new clinical pathway.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lasix ONYU | Other | Drug: Lasix ONYUPatients receiving Lasix ONYU |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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.
- Expected to require a minimum of three days of parenteral diuretic treatment
Key exclusion criteria (9 listed)
- 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
- Home or current living environment not suitable for outpatient management and diuresis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lasix ONYUProviding subcutaneous furosemide to eligible patients | Drug | Lasix ONYU |
Primary outcome
Safety of Lasix ONYU Use
Time frame: 30 days
Adverse reactions, acute kidney injury
1 secondary outcome
Hospital Readmission
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lasix ONYU in people with Heart Failure and Volume Overload, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mustafa M Ahmed, MD (352-273-9065, mustafa.ahmed@medicine.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Lasix ONYU Use (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.