170
Participants
Start Date
November 17, 2022
Primary Completion Date
October 30, 2025
Study Completion Date
October 30, 2025
SQIN-Furosemide
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-Infusor
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.
RECRUITING
Stoke Mandeville Hospital, Aylesbury
RECRUITING
Basildon University Hospital, Basildon
RECRUITING
Blackpool Victoria Hospital, Blackpool
RECRUITING
University Hospitals Dorset, Bournemouth
RECRUITING
Southmead Hospital, Bristol
RECRUITING
University Hospital of North Tees, Hardwick
RECRUITING
Wycombe General Hospital, High Wycombe
RECRUITING
Leeds General Infirmary, Leeds
RECRUITING
Glenfield Hospital, Leicester
RECRUITING
St Thomas' Hospital, London
RECRUITING
St. George's University of London, London
RECRUITING
Manchester Heart Centre, Manchester
RECRUITING
Queen Alexandra Hospital, Portsmouth
RECRUITING
Sunderland Royal Hospital, Sunderland
RECRUITING
University Hospital Ayr, Ayr
RECRUITING
Ninewells Hospital, Dundee
RECRUITING
Glasgow Royal Infirmary, Glasgow
RECRUITING
Forth Valley Hospital, Larbert
RECRUITING
Queen Elizabeth University Hospital, Glasgow
RECRUITING
University Hospital Monklands, Airdrie
RECRUITING
University Hospital Southampton, Southampton
RECRUITING
The Great Western Hospital, Swindon
University of Glasgow
OTHER
NHS Greater Glasgow and Clyde
OTHER