Use of a Novel SUBCUTaneous Preparation of Furosemide to Facilitate Early Supported Discharge of Patients With Heart Failure
NCT ID: NCT05419115
Last Updated: 2025-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
170 participants
INTERVENTIONAL
2022-11-17
2025-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Usual Care
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)
No interventions assigned to this group
Early supported discharge
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.
SQIN-Furosemide
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.
SQIN-Infusor
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.
Interventions
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SQIN-Furosemide
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.
SQIN-Infusor
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.
Eligibility Criteria
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Inclusion Criteria
* Male or female ≥18 years of age
* Meet European Society of Cardiology (ESC) criteria for diagnosis of HF1
* Elevated natriuretic peptide (BNP\> 100 pg/mL or NTproBNP \>300 pg/mL)
* Signs and symptoms of HF
* Echocardiographic structural or functional abnormality according to ESC guidelines
* 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
* Unable to operate SQIN-Infusor (or no caregiver who is able to operate the device)
* Geographical reasons preventing follow-up visits
* Pregnancy or breast-feeding
* Requiring treatment with IV furosemide \>250 mg furosemide per day in the opinion of the treating physician
* Left sided valve disease with planned surgery or percutaneous intervention
* Type 1 myocardial infarction during index hospitalisation (participants with type 2 myocardial infarction can be included)2
* Renal impairment, defined as estimated glomerular filtration rate (eGFR) \< 20 mL/min/1.73 m 2 at screening
* Reasons (other than HF) which may prevent discharge from hospital, such as social circumstances or other significant medical condition (at investigator discretion)
* Women of childbearing potential
* Patient on active cardiac transplant waiting list
* Patient requiring on-going inotropic, vasopressor or intraaortic balloon pump support
* Potassium \<3.0 mmol/L
* Potassium \>6.0 mmol/L
* Sodium \<125 mmol/L
* 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
18 Years
ALL
No
Sponsors
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University of Glasgow
OTHER
NHS Greater Glasgow and Clyde
OTHER
Responsible Party
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Principal Investigators
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Mark Petrie, MBChB
Role: PRINCIPAL_INVESTIGATOR
University of Glasgow
Ross Campbell, MBChB
Role: PRINCIPAL_INVESTIGATOR
University of Glasgow
Locations
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Stoke Mandeville Hospital
Aylesbury, England, United Kingdom
Basildon University Hospital
Basildon, England, United Kingdom
Blackpool Victoria Hospital
Blackpool, England, United Kingdom
University Hospitals Dorset
Bournemouth, England, United Kingdom
Southmead Hospital
Bristol, England, United Kingdom
University Hospital of North Tees
Hardwick, England, United Kingdom
Wycombe General Hospital
High Wycombe, England, United Kingdom
Leeds General Infirmary
Leeds, England, United Kingdom
Glenfield Hospital
Leicester, England, United Kingdom
St Thomas' Hospital
London, England, United Kingdom
St. George's University of London
London, England, United Kingdom
Manchester Heart Centre
Manchester, England, United Kingdom
Queen Alexandra Hospital
Portsmouth, England, United Kingdom
Sunderland Royal Hospital
Sunderland, England, United Kingdom
University Hospital Ayr
Ayr, Scotland, United Kingdom
Ninewells Hospital
Dundee, Scotland, United Kingdom
Glasgow Royal Infirmary
Glasgow, Scotland, United Kingdom
Forth Valley Hospital
Larbert, Scotland, United Kingdom
Queen Elizabeth University Hospital
Glasgow, Strathclyde, United Kingdom
University Hospital Monklands
Airdrie, , United Kingdom
University Hospital Southampton
Southampton, , United Kingdom
The Great Western Hospital
Swindon, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Christopher P Clifford
Role: primary
Henry Savage
Role: primary
Kenneth Wong
Role: primary
Chris Critoph
Role: primary
Chih Wong
Role: primary
Matthew Dewhurst
Role: primary
Christopher P Clifford
Role: primary
Kate Gatenby
Role: primary
Iain Squire
Role: primary
Rebekah Schiff
Role: primary
Robin Ray
Role: primary
Fozia Ahmed
Role: primary
Kaushik Guha
Role: primary
Samuel McClure
Role: primary
Ewan McKay
Role: primary
Ify Mordi
Role: primary
Clare Murphy
Role: primary
Colin Petrie
Role: primary
Peter Cowburn
Role: primary
Paul Foley
Role: primary
Other Identifiers
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2020-004833-19
Identifier Type: -
Identifier Source: org_study_id
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