An at-home heart failure treatment study from the University of Florida reports that 18 of 21 patients at imminent risk of hospital admission had their fluid overload treated at home, without being hospitalised. Interim results from the Gator SCALES-WHF study were presented at the Heart Failure Society of America (HFSA) annual scientific meeting in Phoenix and announced by SQ Innovation on 12 October 2026. The treatment is Lasix ONYU, a subcutaneous form of the diuretic furosemide delivered by a wearable infusor.
The headline is encouraging, but the evidence is thin. The study has 21 patients, one site and no randomised comparison group, so it cannot show that home treatment is better than hospital care. This report explains the device, the patients, the arithmetic behind the 86% figure and what a stronger study would need to show.
At-home heart failure treatment study: the key findings
- Design: prospective, open-label, single-arm, real-world study at the University of Florida, sponsored by the university.
- Patients: 21 adults with worsening heart failure and fluid overload despite higher doses of oral diuretics, judged likely to need at least three days of injected or infused diuretics.
- Outcome reported: 86% (18 of 21) were decongested at home without hospitalisation.
- Hospital admissions: three patients were admitted within 30 days for further treatment.
- Tolerability: the company reports no discontinuations for user, device or adverse-event reasons.
- Registration: NCT06979726 on ClinicalTrials.gov.
How Lasix ONYU works in the at-home heart failure treatment study
Lasix ONYU is a drug-device combination approved by the FDA on 7 October 2025 for oedema in adults with chronic heart failure. It uses a prefilled cartridge holding 80 mg of furosemide and an infusor that delivers the dose under the skin over about five hours. The reusable infusor can be used up to 48 times, and the disposable version has a 29-gauge needle. It follows an earlier subcutaneous furosemide product, Furoscix, approved in 2023.
The idea is simple. Intravenous diuretics given in hospital are a standard way to remove excess fluid in worsening heart failure, but they need a bed or a clinic chair. A subcutaneous option lets a patient do it at home, alone or with a caregiver. The approval itself is not the news here; the new data concern how the drug and device performed in a real-world pathway. Listed side effects include dehydration, low blood pressure, high blood sugar, ringing in the ears, sun sensitivity and infusion-site reactions, and details are in the Drugs@FDA database.
Who was in the at-home heart failure treatment study
The patients were not mildly ill. Their mean age was 63.1 years, 38% were women, and 67% had heart failure with reduced ejection fraction. One report gives a median ejection fraction of 17.5%, with two-thirds at 25% or below, a median BNP of 1,125 pg/mL and a mean eGFR of about 48, which signals reduced kidney function. In our reading, this was a sick group for whom a failed outpatient plan would normally mean admission, which makes the home result notable but also raises the stakes of a poor outcome.
People over 80, those with significant electrolyte abnormalities, those needing further investigation or hospitalisation, and those whose homes were judged unsuitable were excluded, so the results may not apply to every patient.
Reading the 86% figure from the at-home heart failure treatment study
Eighteen of 21 is 85.7%, so the rounded 86% is correct. The more useful question is how precise it is. By our calculation, an approximate 95% confidence interval for 18 of 21 runs from roughly 65% to 95%, meaning a true success rate anywhere in that range is consistent with these data. That is our own estimate, not a figure from the study team. A larger sample would narrow the range.
The timing of the admissions is also worth noting. One report says no emergency visits or admissions occurred by day three, one patient was hospitalised after an emergency visit by day seven, and three had been admitted by day 20. The summaries do not say whether the day-seven patient is among the three, so we cannot reconcile them. The company describes 95 doses given in total, while another report says 95 of 104 applications succeeded, a difference the sources do not explain.
What the at-home heart failure treatment study cannot show
- It has no comparison group, so it cannot say whether patients would have done as well, better or worse in hospital or on another outpatient plan.
- It is open-label and interim, with 21 patients at a single site.
- Its stated aim is to develop and evaluate a clinical pathway for home treatment, not to prove superiority.
- The company says the set-up involved “study-related constraints” but does not list them, so the support patients received is unclear.
- Nothing in the summaries covers cost, or readmission beyond 30 days.
Patient experience in the at-home heart failure treatment study
One report cites a patient survey in which 92% found the device easy to use, 83% preferred home treatment to hospitalisation and 67% reported symptom improvement. The number of respondents was not given, so with a group this size each answer moves the percentages substantially. Still, preferences matter in care that patients carry out themselves.
What happens next for the at-home heart failure treatment study
The study is continuing toward a protocol target of 100 patients who complete treatment, and the investigators plan to add a comparison group of contemporaneous patients receiving oral diuretic escalation with sequential nephron blockade. That would be a more informative design, although still not randomised. For related cardiovascular reading, see our report on tovinontrine in heart failure with reduced ejection fraction and on new aprocitentan hypertension analyses, plus our wider medical device coverage. General background on the condition is available from the US National Heart, Lung, and Blood Institute.
Our assessment of the at-home heart failure treatment study
In our assessment, this is a feasibility signal, not evidence of superiority. It suggests that selected patients can manage subcutaneous diuretic therapy at home, and that hospital teams can build a pathway around it. Whether that reduces admissions overall, safely, and at acceptable cost is a question for the larger and better controlled studies still to come.
Frequently asked questions
What did the at-home heart failure treatment study find?
Of 21 patients at imminent risk of admission, 18 (86%) were treated for fluid overload at home without hospitalisation, and three were admitted within 30 days.
Does the at-home heart failure treatment study prove home beats hospital?
No. There was no comparison group, and the sample was small.
What is Lasix ONYU?
An FDA-approved drug-device combination that delivers furosemide under the skin through a wearable infusor. It was approved in October 2025.
Where was the study done?
At the University of Florida, and presented at the Heart Failure Society of America meeting.
How we reported this: we relied on the company announcement of 12 October 2026, a report of the HFSA presentation and the study’s registry entry. We did not see the full data. Figures labelled as ours are our own calculations. Last updated: 13 October 2026. This article is news reporting and not medical advice.