Status:
RECRUITING
Use of a Novel SUBCUTaneous Preparation of Furosemide to Facilitate Early Supported Discharge of Patients With Heart Failure
Lead Sponsor:
NHS Greater Glasgow and Clyde
Collaborating Sponsors:
University of Glasgow
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 (deli...
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) diur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2025
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT05419115
Start Date
November 17 2022
End Date
October 30 2025
Last Update
April 15 2025
Active Locations (22)
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1
Stoke Mandeville Hospital
Aylesbury, England, United Kingdom, HP21 8AL
2
Basildon University Hospital
Basildon, England, United Kingdom, SS16 5NL
3
Blackpool Victoria Hospital
Blackpool, England, United Kingdom, FY3 8NR
4
University Hospitals Dorset
Bournemouth, England, United Kingdom, BH7 7DW