Clinical trial NCT05419115: Use of a Novel SUBCUTaneous Preparation of Furosemide to Facilitate Early Supported Discharge of Patients With Heart Failure
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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Heart Failure
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Glasgow
First posted: 2022-06-15
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised, parallel-group, active comparator controlled trial
Primary purpose: TREATMENT

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.

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

  * 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 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
* 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

Primary outcomes:
measure: Days Alive Out of Hospital
timeFrame: 30 days
Secondary outcomes:
measure: Length of index hospitalisation
timeFrame: 30 days
measure: Change in quality of life
timeFrame: 60 days
measure: Days Alive Out of Hospital
timeFrame: 60 days
measure: Total number of HF hospitalisations at 60 days
timeFrame: 60 days
measure: CV death or first HF hospitalisation at 60 days
timeFrame: 60 days
measure: CV mortality at 60 days
timeFrame: 60 days
measure: 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])
timeFrame: 60 days
measure: Any device failures (e.g., adhesive failure and drug delivery failure)
timeFrame: 60 days
Other outcomes:
Locations:
city: Aylesbury
country: United Kingdom
facility: Stoke Mandeville Hospital
state: England
city: Basildon
country: United Kingdom
facility: Basildon University Hospital
state: England
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
state: England
city: Bournemouth
country: United Kingdom
facility: University Hospitals Dorset
state: England
city: Bristol
country: United Kingdom
facility: Southmead Hospital
state: England
city: Hardwick
country: United Kingdom
facility: University Hospital of North Tees
state: England
city: High Wycombe
country: United Kingdom
facility: Wycombe General Hospital
state: England
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
state: England
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
state: England
city: London
country: United Kingdom
facility: St Thomas' Hospital
state: England
city: London
country: United Kingdom
facility: St. George's University of London
state: England
city: Manchester
country: United Kingdom
facility: Manchester Heart Centre
state: England
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
state: England
city: Sunderland
country: United Kingdom
facility: Sunderland Royal Hospital
state: England
city: Ayr
country: United Kingdom
facility: University Hospital Ayr
state: Scotland
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
state: Scotland
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
state: Scotland
city: Larbert
country: United Kingdom
facility: Forth Valley Hospital
state: Scotland
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
state: Strathclyde
city: Airdrie
country: United Kingdom
facility: University Hospital Monklands
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
city: Swindon
country: United Kingdom
facility: The Great Western Hospital
Study officials:
affiliation: University of Glasgow
name: Mark Petrie, MBChB
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Glasgow
name: Ross Campbell, MBChB
role: PRINCIPAL_INVESTIGATOR
References: