At-Home Subcutaneous Furosemide Treatment Reduces Worsening HF Hospitalizations

Early data from the Gator SCALES-WHF trial have demonstrated at-home subcutaneous furosemide’s efficacy as an alternative to hospital-based IV diuresis in worsening heart failure (WHF).1

These data were presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026 in Phoenix, Arizona, by Mustafa Ahmed, MD, assistant professor of medicine in advanced heart failure and transplantation at the University of Florida.1

“The thought process behind the trial is that clinicians are often seeing patients in clinic who are clearly volume overloaded due to failed up-titration of oral diuretics,” Ahmed told HCPLive in an exclusive interview. “While we in our clinic have the ability to give intravenous diuretics in the clinic, we want to have a sustainable escalated therapy to keep them out of the hospital or the emergency room.”

Gator SCALES-WHF is an open-label, non-comparative real-world study aiming to evaluate the effectiveness and feasibility of at-home decongestion with the Lasix ONYU in patients with WHF. Patients are eligible for inclusion if they were previously diagnosed with congestive heart failure, regardless of ejection fraction, and have failed oral up-titration of loop diuretics, among other criteria. Patients are excluded if they are >80 years of age and have electrolyte abnormalities that could be exacerbated by parenteral loop diuretic treatment, among other criteria.2

The primary outcome is the safety of Lasix ONYU usage, determined via the presence of adverse reactions or acute kidney injury (AKI) at 30 days. The main secondary outcome is hospital readmission at 30 days after Lasix ONYU administration. Ahmed and colleagues also conducted follow-up to measure patients’ creatinine, eGFR, and potassium levels.1,2

A total of 21 patients were included in the current results, with a mean age of 63.1 +/- 12 years. Of the enrolled and treated patients, 67% had HF with reduced ejection fraction (HFrEF), while 29% had HF with preserved ejection fraction (HFpEF) and 5% had obstructive hypertrophic cardiomyopathy (oHCM). Median left ventricular ejection fraction (LVEF) at baseline was 17.5 (interquartile range [IQR], 15-57), and 67% of patients had an LVEF ≤25%. Baseline creatinine was 1.7 +/- 0.61 mg/dL, while baseline eGFR was 48.4 +/- 22.3 mL/min/1.73m2.1

At day 3 after Lasix ONYU administration, no patients had undergone an emergency room visit or hospitalization for HF. By day 7, Ahmed and colleagues saw 1 patient hospitalized following an emergency room visit, and by day 20, 3 patients had been admitted. During this time period, 91% of all furosemide applications were successful (95/104), and only 1 device-related adverse event – a detachment – was recorded.1

The team also surveyed patients on their experience with the device. Of the 21 patients enrolled in the trial, 92% reported that the Lasix ONYU was easy to use and that they were capable of performing daily activities. Another 83% preferred home treatment over hospitalization and would recommend the device for other patients. 67% of patients reported seeing their symptoms improve.1

Ultimately, Ahmed and colleagues determined that these early data further support their decision to continue toward the protocol target of 100 patients completing treatment and expressed their intention to broaden recruitment moving forward. Additionally, the team intends to add a comparator by matching against contemporaneous patients who will receive augmentation of diuresis via multisegment nephron blockade with escalation of oral loop diuretics.1

“The real hallmark of the study is that patients were getting the device and all of its refill cartridges at the time they saw us in the clinic, so they didn’t need to come back for any additional therapy,” Ahmed said. “That is a pragmatic protocol design that utilizes only standard-of-care labs and normal operations, not adding a bunch of clunkiness. It can be done in a busy heart failure clinic.”

Editors’ Note: Ahmed reports no relevant disclosures.

References

1. ElSaygh J, Villaroel L, O’Shea A, et al. GATORSCALES-WHF: SubCutaneous Administration of Lasix to Eliminate Symptoms of Worsening Heart Failure. Presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026, Phoenix, AZ. October 9-12, 2026.

2. University of Florida. Gator SCALES-WHF: SubCutaneous Administration of Lasix to Eliminate Symptoms of Worsening Heart Failure (GatorScalesWHF). ClinicalTrials.gov Identifier: NCT06979726. Updated June 8, 2026. Accessed October 11, 2026. https://clinicaltrials.gov/study/NCT06979726?term=NCT06979726&rank=1