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| Name | Class |
|---|---|
| University of Glasgow | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | 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) | |
| Early supported discharge | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SQIN-Furosemide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Days Alive Out of Hospital | Days spent alive and out of hospital (DAOH), from randomisation to 30 days. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of index hospitalisation | Length of index hospitalisation | 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] |
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Inclusion Criteria:
Written informed consent
Male or female ≥18 years of age
Meet European Society of Cardiology (ESC) criteria for diagnosis of HF1
Have received IV diuretic for treatment of HF within preceding 24 hours
Be less than 96 hours after admission to hospital
Requiring IV diuretics for a minimum of 24 hours after screening
Have an echocardiogram or other assessment of cardiac structure and function within preceding 12 months or at screening
Have a home environment that allows the patient to be able to mobilise within their residence and be able to pass urine into their toilet (unless catheterised)
Able to operate (or has a caregiver who can operate) SQIN-Infusor (as assessed by training on a dummy device at screening)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Petrie, MBChB | University of Glasgow | Principal Investigator |
| Ross Campbell, MBChB | University of Glasgow | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stoke Mandeville Hospital | Aylesbury | England | HP21 8AL | United Kingdom | ||
| Basildon University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41771109 | Derived | Campbell RT, Osmanska J, Docherty KF, Ahmed FZ, Clark AL, Clayton L, Cleland JGF, Critoph C, Dewhurst M, Hartshorne-Evans N, Gardner RS, Gatenby KV, Guha K, Kalra PR, Lees A, McConnachie A, Muntendam P, Mowat K, O'Donnell J, Placzek A, Ray R, Savage HO, Schiff R, Squire I, Wetherall K, Wong K, Wong C, McMurray JJV, Petrie MC. SUBCUT HF II: rationale and design of a multicentre randomized controlled trial of SUBCUTaneous furosemide to support early discharge in patients admitted to hospital due to Heart Failure. Eur J Heart Fail. 2026 May 2;28(1):121-129. doi: 10.1093/ejhf/xuaf018. |
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randomised, parallel-group, active comparator controlled trial
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| SQIN-Infusor | Device | 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. |
|
| 60 days |
| Days Alive Out of Hospital | Days spent alive and out of hospital (DAOH), from randomisation to 60 days. | 60 days |
| Total number of HF hospitalisations at 60 days | Total number of HF hospitalisations at 60 days | 60 days |
| CV death or first HF hospitalisation at 60 days | CV death or first HF hospitalisation at 60 days | 60 days |
| CV mortality at 60 days | CV mortality at 60 days | 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]) | 60 days |
| Any device failures (e.g., adhesive failure and drug delivery failure) | Any device failures (e.g., adhesive failure and drug delivery failure) | 60 days |
| Basildon |
| England |
| SS16 5NL |
| United Kingdom |
| Blackpool Victoria Hospital | Blackpool | England | FY3 8NR | United Kingdom |
| University Hospitals Dorset | Bournemouth | England | BH7 7DW | United Kingdom |
| Southmead Hospital | Bristol | England | BS10 5NB | United Kingdom |
| University Hospital of North Tees | Hardwick | England | TS19 8PE | United Kingdom |
| Wycombe General Hospital | High Wycombe | England | HP11 2TT | United Kingdom |
| Leeds General Infirmary | Leeds | England | LS1 3EX | United Kingdom |
| Glenfield Hospital | Leicester | England | LE3 9QP | United Kingdom |
| St Thomas' Hospital | London | England | SE1 7EH | United Kingdom |
| St. George's University of London | London | England | SW17 0RE | United Kingdom |
| Manchester Heart Centre | Manchester | England | M13 9WL | United Kingdom |
| Queen Alexandra Hospital | Portsmouth | England | PO6 3LY | United Kingdom |
| Sunderland Royal Hospital | Sunderland | England | SR4 7TP | United Kingdom |
| University Hospital Ayr | Ayr | Scotland | KA6 6DX | United Kingdom |
| Ninewells Hospital | Dundee | Scotland | DD1 9SY | United Kingdom |
| Glasgow Royal Infirmary | Glasgow | Scotland | G12 8TA | United Kingdom |
| Forth Valley Hospital | Larbert | Scotland | FK5 4WR | United Kingdom |
| Queen Elizabeth University Hospital | Glasgow | Strathclyde | G51 4TF | United Kingdom |
| The Great Western Hospital | Swindon | United Kingdom | SN3 6BB | United Kingdom |
| University Hospital Monklands | Airdrie | ML6 0JS | United Kingdom |
| University Hospital Southampton | Southampton | United Kingdom |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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