A Phase 2 interventional study of SQIN-Furosemide and SQIN-Infusor in Heart Failure, sponsored by NHS Greater Glasgow and Clyde. Completed at 22 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by NHS Greater Glasgow and Clyde · Phase 2, Interventional, and Treatment
To investigate whether an early supported discharge strategy for patients admitted to hospital because of HF, using a pH neutral subcutaneous (SC) furosemide formulation (SQINFurosemide) at home (delivered by non-CE marked SQINInfusor), compared to a usual care strategy with intravenous (IV) furosemide in hospital, results in an increased number of days spent alive and out of hospital (DAOH) at 30 days.
HF is associated with frequent and lengthy hospitalisations. These hospitalisations are usually as a result of congestion, and the standard treatment of this is decongestion with intravenous (IV) diuretic (usually furosemide). This is usually delivered in a hospital setting. A new formulation of a pHneutral furosemide (SQIN-Furosemide) that can be delivered subcutaneously (SC) by a small patch pump (SQIN-Infusor) has been developed. Bioavailability of SQIN-Furosemide is similar to IV furosemide. This trial will test the efficacy and safety of novel SC furosemide 30mg/ml (SQIN-Furosemide), delivered in a home environment (compared to usual care strategy with IV furosemide delivered in secondary care) as part of a novel early supported discharge strategy in patients admitted to hospital with HF.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 172 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →NHS Greater Glasgow and Clyde is the lead sponsor of 215 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Meet European Society of Cardiology (ESC) criteria for diagnosis of HF1
Exclusion Criteria:
Open label, 1:1 randomisation to usual care in hospital vs early supported discharge with SQIN-Furosemide administered via SQIN-Infusor. Usual care: Usual care as per institutional practice (including IV diuretics)
Open label, 1:1 randomisation to usual care in hospital vs early supported discharge with SQIN-Furosemide administered via SQIN-Infusor. Early supported discharge: with SQIN-Furosemide and SQIN-Infusor. SQIN-Furosemide: 80mg of SQIN-Furosemide in each cartridge; 5 hours running time; up to 2 applications in 24h (maximum dose of 160mg of SQIN-Furosemide in 24h). SQIN-Infusor: patient/carer administered.
Drug: SQIN-Furosemide · Device: SQIN-Infusor
The investigational furosemide formulation (SQIN-Furosemide) is a Captisol®buffered solution of 80mg furosemide in 2.7 mL (30 mg/mL) at pH 7.4 (range: 7.0 to 7.8). SC infusion will be performed using the SQIN-Infusor which will deliver 2.7 mL of the SQIN-Furosemide formulation (80mg) over approximately 5 hours, using a biphasic delivery profile.
The investigational device (SQIN-Infusor) is an on-body delivery system that consists of a RU, DU, plus a charger (Figure 2). For the purpose of SUBCUT-HF II trial, the RU will be used for multiple infusions for a single participant. The DU will be used only once per infusion and disposed of. The RU must be charged after each use and will not restart for the next infusion without charging. Charging takes up to 15 minutes. SQIN-Infusor is a bespoke system, adapted from the design of a SC insulin pump. The RU consists of the drive-unit, the controllers, the rechargeable battery, and the user interface.
Days Alive Out of Hospital
Days spent alive and out of hospital (DAOH), from randomisation to 30 days.
Time frame: 30 days
Length of index hospitalisation
Length of index hospitalisation
Time frame: 30 days
Change in quality of life
Change in quality of life at 60 days (assessed by Kansas City Cardiomyopathy Questionnaire \[KCCQ-12\]) \[0-100\]
Time frame: 60 days
Days Alive Out of Hospital
Days spent alive and out of hospital (DAOH), from randomisation to 60 days.
Time frame: 60 days
Total number of HF hospitalisations at 60 days
Total number of HF hospitalisations at 60 days
Time frame: 60 days
CV death or first HF hospitalisation at 60 days
CV death or first HF hospitalisation at 60 days
Time frame: 60 days
CV mortality at 60 days
CV mortality at 60 days
Time frame: 60 days
Safety as determined by treatment emergent adverse events (TEAEs) (including serious adverse events [SAEs]) and adverse drug events (ADEs) (including serious adverse drug events [SADEs])
Safety as determined by treatment emergent adverse events (TEAEs) (including serious adverse events \[SAEs\]) and adverse drug events (ADEs) (including serious adverse drug events \[SADEs\])
Time frame: 60 days
Any device failures (e.g., adhesive failure and drug delivery failure)
Any device failures (e.g., adhesive failure and drug delivery failure)
Time frame: 60 days
Plan to share: Undecided
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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NHS Greater Glasgow and Clyde