Heart FailurePhase 2SUBCUT-HF IINCT05419115
Use of a Novel SUBCUTaneous Preparation of Furosemide to Facilitate Early Supported Discharge of Patients With Heart Failure
A Phase 2 study testing SQIN-Furosemide and SQIN-Infusor in people with Heart Failure, run by NHS Greater Glasgow and Clyde at 22 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- SQIN-Furosemide and SQIN-Infusor
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 22 sitesUnited Kingdom
- Study dates
- 17 Nov 2022to 1 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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)
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United Kingdom22 sites
University Hospital Monklands
Airdrie, ML6 0JS
Stoke Mandeville Hospital
Aylesbury, England, HP21 8AL
University Hospital Ayr
Ayr, Scotland, KA6 6DX
Basildon University Hospital
Basildon, England, SS16 5NL
Blackpool Victoria Hospital
Blackpool, England, FY3 8NR
University Hospitals Dorset
Bournemouth, England, BH7 7DW
Southmead Hospital
Bristol, England, BS10 5NB
Ninewells Hospital
Dundee, Scotland, DD1 9SY
Glasgow Royal Infirmary
Glasgow, Scotland, G12 8TA
Queen Elizabeth University Hospital
Glasgow, Strathclyde, G51 4TF
University Hospital of North Tees
Hardwick, England, TS19 8PE
Wycombe General Hospital
High Wycombe, England, HP11 2TT
Forth Valley Hospital
Larbert, Scotland, FK5 4WR
Leeds General Infirmary
Leeds, England, LS1 3EX
Glenfield Hospital
Leicester, England, LE3 9QP
St Thomas' Hospital
London, England, SE1 7EH
St. George's University of London
London, England, SW17 0RE
Manchester Heart Centre
Manchester, England, M13 9WL
Queen Alexandra Hospital
Portsmouth, England, PO6 3LY
University Hospital Southampton
Southampton
Sunderland Royal Hospital
Sunderland, England, SR4 7TP
The Great Western Hospital
Swindon, United Kingdom, SN3 6BB
About this study
Official title: Use of a Novel SUBCUTaneous Preparation of Furosemide to Facilitate Early Supported Discharge of Patients With Heart Failure: a Multicentre, Phase II, Randomised, Parallel Group, Active Comparator Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Heart Failure
- Being tested
- SQIN-Furosemide, SQIN-Infusor
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SQIN-FurosemideDrug
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-InfusorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: SQIN-Furosemide; Device: SQIN-Infusor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days Alive Out of Hospital
Days spent alive and out of hospital (DAOH), from randomisation to 30 days.
Measured: 30 days
Secondary outcomes (8)
Length of index hospitalisation
Length of index hospitalisation
Measured: 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]
Measured: 60 days
Days Alive Out of Hospital
Days spent alive and out of hospital (DAOH), from randomisation to 60 days.
Measured: 60 days
Total number of HF hospitalisations at 60 days
Total number of HF hospitalisations at 60 days
Measured: 60 days
CV death or first HF hospitalisation at 60 days
CV death or first HF hospitalisation at 60 days
Measured: 60 days
CV mortality at 60 days
CV mortality at 60 days
Measured: 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])
Measured: 60 days
Any device failures (e.g., adhesive failure and drug delivery failure)
Any device failures (e.g., adhesive failure and drug delivery failure)
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start17 Nov 2022
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised, parallel-group, active comparator controlled trial
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Mark Petrie, MBChB, Principal investigator, University of GlasgowRoss Campbell, MBChB, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419115
- Sponsor's protocol ID
- 2020-004833-19
- Acronym
- SUBCUT-HF II
- Status last verified
- Mar 2026
- First submitted
- 10 Jun 2022
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Campbell RT, Osmanska J, Docherty KF, Ahmed FZ, Clark AL, Clayton L, Cleland JGF, Critoph C, Dewhurst M, Hartshorne-Evans N, Gardner RS, Gatenby K, Guha K, Jackson CE, Kalra P, Lees A, Martin K, McGlynn L, Mowat K, Muntendam P, O'Donnell J, Placzek A, Owens C, Ray R, Savage HO, Schiff R, Squire I, Wong C, Wong K, McConnachie A, McMurray JJV, Petrie MC; SUBCUT HF II Investigators. Early Discharge Strategy Including Subcutaneous Furosemide in Hospitalized Heart Failure. J Am Coll Cardiol. 2026 Oct 13;88(15):1781-1793. doi: 10.1016/j.jacc.2026.07.047.
PubMed 42872757Campbell 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.
PubMed 41771109
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Novel SUBCUTaneous Preparation of Furosemide to Facilitate Early Supported Discharge of Patients With Heart Failure: a Multicentre, Phase II, Randomised, Parallel Group, Active Comparator Controlled Trial
- ClinicalTrials.gov ID
- NCT05419115
- Acronym / sponsor ID
- SUBCUT-HF II / 2020-004833-19
- Conditions
- Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomised, parallel-group, active comparator controlled trial
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: SQIN-Furosemide, Device: SQIN-InfusorOpen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SQIN-FurosemideThe 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. | Drug | Early supported discharge |
| SQIN-InfusorThe 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. | Device | Early supported discharge |
Primary outcome
Days Alive Out of Hospital
Time frame: 30 days
Days spent alive and out of hospital (DAOH), from randomisation to 30 days.
8 secondary outcomes
Length of index hospitalisation
Time frame: 30 days
Change in quality of life
Time frame: 60 days
Days Alive Out of Hospital
Time frame: 60 days
Total number of HF hospitalisations at 60 days
Time frame: 60 days
CV death or first HF hospitalisation at 60 days
Time frame: 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])
Time frame: 60 days
Any device failures (e.g., adhesive failure and drug delivery failure)
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Derived from this study: PubMed 42872757Campbell RT, Osmanska J, Docherty KF, Ahmed FZ, Clark AL, Clayton L, Cleland JGF, Critoph C, Dewhurst M, Hartshorne-Evans N, Gardner RS, Gatenby K, Guha K, Jackson CE, Kalra P, Lees A, Martin K, McGlynn L, Mowat K, Muntendam P, O'Donnell J, Placzek A, Owens C, Ray R, Savage HO, Schiff R, Squire I, Wong C, Wong K, McConnachie A, McMurray JJV, Petrie MC; SUBCUT HF II Investigators. Early Discharge Strategy Including Subcutaneous Furosemide in Hospitalized Heart Failure. J Am Coll Cardiol. 2026 Oct 13;88(15):1781-1793. doi: 10.1016/j.jacc.2026.07.047.
- Derived from this study: PubMed 41771109Campbell 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.
- Individual participant dataSharing planned: Undecided
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Petrie, MBChB principal investigator
University of Glasgow
Ross Campbell, MBChB principal investigator
University of Glasgow
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SQIN-Furosemide and SQIN-Infusor in people with Heart Failure, run by NHS Greater Glasgow and Clyde at 22 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days Alive Out of Hospital (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05419115, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.