search
Back to results

Use of a Novel SUBCUTaneous Preparation of Furosemide to Facilitate Early Supported Discharge of Patients With Heart Failure (SUBCUT-HF II)

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
SQIN-Furosemide
SQIN-Infusor
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Written informed consent

    • Male or female ≥18 years of age
    • Meet European Society of Cardiology (ESC) criteria for diagnosis of HF1 o Elevated natriuretic peptide (BNP> 100 pg/mL or NTproBNP >300 pg/mL) o Signs and symptoms of HF o Echocardiographic structural or functional abnormality according to ESC guidelines (Appendix B)
    • 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 demonstrated an adequate diuresis with IV diuretic in the preceding 24 hours (defined as any weight loss or > 500 mLs negative fluid balance)
    • 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 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 >200 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

Sites / Locations

  • Glasgow Royal InfirmaryRecruiting
  • Queen Elizabeth University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Early supported discharge

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Length of index hospitalisation
Length of index hospitalisation
Change in quality of life
Change in quality of life at 60 days (assessed by Kansas City Cardiomyopathy Questionnaire [KCCQ-12])
Days Alive Out of Hospital
Days spent alive and out of hospital (DAOH), from randomisation to 60 days.
Total number of HF hospitalisations at 60 days
Total number of HF hospitalisations at 60 days
CV death or first HF hospitalisation at 60 days
CV death or first HF hospitalisation at 60 days
CV mortality at 60 days
CV mortality at 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])
Any device failures (e.g., adhesive failure and drug delivery failure)
Any device failures (e.g., adhesive failure and drug delivery failure)

Full Information

First Posted
June 10, 2022
Last Updated
November 17, 2022
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
search

1. Study Identification

Unique Protocol Identification Number
NCT05419115
Brief Title
Use of a Novel SUBCUTaneous Preparation of Furosemide to Facilitate Early Supported Discharge of Patients With Heart Failure
Acronym
SUBCUT-HF II
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2022 (Actual)
Primary Completion Date
May 28, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
randomised, parallel-group, active comparator controlled trial
Masking
None (Open Label)
Masking Description
Not possible
Allocation
Randomized
Enrollment
550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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)
Arm Title
Early supported discharge
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SQIN-Furosemide
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
SQIN-Infusor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Days Alive Out of Hospital
Description
Days spent alive and out of hospital (DAOH), from randomisation to 30 days.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Length of index hospitalisation
Description
Length of index hospitalisation
Time Frame
30 days
Title
Change in quality of life
Description
Change in quality of life at 60 days (assessed by Kansas City Cardiomyopathy Questionnaire [KCCQ-12])
Time Frame
60 days
Title
Days Alive Out of Hospital
Description
Days spent alive and out of hospital (DAOH), from randomisation to 60 days.
Time Frame
60 days
Title
Total number of HF hospitalisations at 60 days
Description
Total number of HF hospitalisations at 60 days
Time Frame
60 days
Title
CV death or first HF hospitalisation at 60 days
Description
CV death or first HF hospitalisation at 60 days
Time Frame
60 days
Title
CV mortality at 60 days
Description
CV mortality at 60 days
Time Frame
60 days
Title
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])
Description
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
Title
Any device failures (e.g., adhesive failure and drug delivery failure)
Description
Any device failures (e.g., adhesive failure and drug delivery failure)
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent Male or female ≥18 years of age Meet European Society of Cardiology (ESC) criteria for diagnosis of HF1 o Elevated natriuretic peptide (BNP> 100 pg/mL or NTproBNP >300 pg/mL) o Signs and symptoms of HF o Echocardiographic structural or functional abnormality according to ESC guidelines (Appendix B) 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 demonstrated an adequate diuresis with IV diuretic in the preceding 24 hours (defined as any weight loss or > 500 mLs negative fluid balance) 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 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 >200 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Petrie, MBChB
Phone
0141 330 2427
Email
mark.petrie@glasgow.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Ross Campbell, MBChB
Phone
01413302418
Email
ross.campbell@glasgow.ac.uk
Facility Information:
Facility Name
Glasgow Royal Infirmary
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 8TA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Petrie, MBChB
Phone
01413302418
Email
mark.petrie@glasgow.ac.uk
First Name & Middle Initial & Last Name & Degree
Joanna Osmanska, MBChB
Email
joanna.osmanska@glasgow.ac.uk
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
State/Province
Strathclyde
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ross Campbell, MBChB
Email
ross.campbell@glasgow.ac.uk
First Name & Middle Initial & Last Name & Degree
Joanna Osmanska, MBChB
Email
joanna.osmanska@glasgow.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs