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Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 to 80

Subcutaneous Lasix ONYU for at-home treatment of worsening heart failure

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

Run by University of Florida · NCT06979726 · Data updated 2026-11-12

This test will see if giving Lasix through a small subcutaneous device at home relieves fluid overload in adults with worsening heart failure.

More Heart Failure trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment100 (estimated)
SponsorUniversity of Florida
Academic / other
Locations1 site (Gainesville, Florida)
StatusRecruiting
StartedNovember 20, 2025
Main results expectedNovember 30, 2026
Study endsDecember 31, 2026
Registry record updatedJune 8, 2026
Trial IDNCT06979726 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–80 with known heart failure (HFrEF or HFpEF) who present with objective signs of volume overload, require parenteral diuretics, have failed or cannot tolerate oral uptitration, expect at least three days of parenteral therapy, and can operate the device or have a caregiver to do so.

Probably not a fit

Patients over 80, those requiring immediate hospitalization or further inpatient evaluation, those unable to consent or operate the device, or those with other acute medical conditions are unlikely to benefit from this at-home approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, non-comparative real-world study implements a clinic-specific pathway to deliver subcutaneous Lasix ONYU for at-home decongestion in patients with worsening heart failure. Patients presenting to the UF Heart Failure Clinic, Emergency Department, or Clinical Decision Unit who meet objective criteria for volume overload and require parenteral diuretics are screened and enrolled. Enrolled patients (or their caregivers) are trained to operate the device and receive repeated subcutaneous diuretic administration over at least three days with symptom and safety monitoring. Investigators will collect feasibility, device operation, safety data, and identify process improvements prior to routine implementation.

Why it matters

Potential benefit: If successful, this approach could allow eligible patients to get parenteral diuretics at home to relieve congestion and potentially avoid hospital admission.

How similar studies have gone: Small studies and case reports of subcutaneous furosemide have shown promising decongestion, but routine home use with a dedicated device like Lasix ONYU is relatively novel and not yet widely tested.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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 informed consent
7. Able and willing to operate Lasix ONYU and comply with study requirements or has a caregiver who can assume these roles.

Exclusion Criteria:

1. Age above 80 years
2. Unable or unwilling to provide informed consent.
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

Where it's running

  • University of Florida
    Gainesville, Florida, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.