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

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

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

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of Florida (Academic / other)
• Locations: 1 site (Gainesville, Florida)
• Trial ID: NCT06979726 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Gainesville, Florida

• University of Florida — Gainesville, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Mustafa M Ahmed, MD

Conditions Heart Failure; Volume Overload