Use of a Novel SUBCUTaneous Preparation of Furosemide to Facilitate Early Supported Discharge of Patients With Heart Failure

NCT05419115 | Completed Phase 2 DMC

• 1 other identifier: 2020-004833-19
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 22

Brief Summary

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Days Alive Out of Hospital

  Days spent alive and out of hospital (DAOH), from randomisation to 30 days.

  30 days

Secondary Outcomes (8)

• Length of index hospitalisation

  30 days

• Change in quality of life

  60 days

• Days Alive Out of Hospital

  60 days

• Total number of HF hospitalisations at 60 days

  60 days

• CV death or first HF hospitalisation at 60 days

  60 days

Study Arms (2)

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.

Drug: SQIN-Furosemide; Device: SQIN-Infusor

Interventions

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.

Early supported discharge

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.

Early supported discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• 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)

You may not qualify if:

• Unable to consent due to significant cognitive impairment or lack of capacity
• 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

Sponsors & Collaborators

• University of Glasgow: collaborator
• NHS Greater Glasgow and Clyde: lead

Study Sites (22)

Stoke Mandeville Hospital

Aylesbury, England, HP21 8AL, United Kingdom

Location

Basildon University Hospital

Basildon, England, SS16 5NL, United Kingdom

Location

Blackpool Victoria Hospital

Blackpool, England, FY3 8NR, United Kingdom

Location

University Hospitals Dorset

Bournemouth, England, BH7 7DW, United Kingdom

Location

Southmead Hospital

Bristol, England, BS10 5NB, United Kingdom

Location

University Hospital of North Tees

Hardwick, England, TS19 8PE, United Kingdom

Location

Wycombe General Hospital

High Wycombe, England, HP11 2TT, United Kingdom

Location

Leeds General Infirmary

Leeds, England, LS1 3EX, United Kingdom

Location

Glenfield Hospital

Leicester, England, LE3 9QP, United Kingdom

Location

St Thomas' Hospital

London, England, SE1 7EH, United Kingdom

Location

St. George's University of London

London, England, SW17 0RE, United Kingdom

Location

Manchester Heart Centre

Manchester, England, M13 9WL, United Kingdom

Location

Queen Alexandra Hospital

Portsmouth, England, PO6 3LY, United Kingdom

Location

Sunderland Royal Hospital

Sunderland, England, SR4 7TP, United Kingdom

Location

University Hospital Ayr

Ayr, Scotland, KA6 6DX, United Kingdom

Location

Ninewells Hospital

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Glasgow Royal Infirmary

Glasgow, Scotland, G12 8TA, United Kingdom

Location

Forth Valley Hospital

Larbert, Scotland, FK5 4WR, United Kingdom

Location

Queen Elizabeth University Hospital

Glasgow, Strathclyde, G51 4TF, United Kingdom

Location

The Great Western Hospital

Swindon, United Kingdom, SN3 6BB, United Kingdom

Location

University Hospital Monklands

Airdrie, ML6 0JS, United Kingdom

Location

University Hospital Southampton

Southampton, United Kingdom

Location

Related Publications (1)

• 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 Jan 12:xuaf018. doi: 10.1093/ejhf/xuaf018. Online ahead of print.

  PMID: 41771109 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Mark Petrie, MBChB

  University of Glasgow

  PRINCIPAL INVESTIGATOR

• Ross Campbell, MBChB

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not possible
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomised, parallel-group, active comparator controlled trial

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 15, 2022
• Study Start: November 17, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

GB (22)