SUBCUT-HF II
Research type
Research Study
Full 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
IRAS ID
292091
Contact name
Mark C Petrie
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Eudract number
2020-004833-19
Duration of Study in the UK
3 years, 3 months, 1 days
Research summary
Heart failure is the most common reason for hospital admission in those over the age of 65 and accounts for 5% of all emergency admissions. Excessive fluid accumulation (congestion) is the primary reason for hospitalisation for heart failure and the majority of patients require multi-day therapy with intravenous diuretics, which can be administered only in the hospital, leading to prolonged admissions. This need for inpatient care has prompted attempts to develop alternative treatments with diuretics without the need for intravenous administration. The reduction in length of hospital stay would reduce costs, improve patients’ quality of life and minimise any hospital-related harm.
Furosemide has been in use for over 50 years to relieve symptoms of congestion, however it can cause significant skin irritation and discomfort if administered subcutaneously. To address this issue, a new skin friendly preparation of furosemide, called SQIN-Furosemide, which can be administered with patch-pump device (SQIN-Infusor), has been developed. The treatment with combination of SQIN-Furosemide and SQIN-Infusor has been tested in Phase I clinical trial, with good clinical results and no safety concerns.
In this phase II trial, a total of 550 patients admitted with heart failure will be recruited. Eligible patients will be randomised to early supported discharge (using SQIN-Furosemide with SQIN-Infusor at home) or usual inpatient care with intravenous diuretics. For all participants we will measure weight, perform blood tests, electrocardiogram, update ultrasound of heart and ask questions about symptoms and quality of life.
Participants allocated to the usual care treatment arm will continue inpatient care guided by their usual care team. Participants randomised to early supported discharge will be reviewed every 3 days (and daily phone call for the first 20 patients in Glasgow) while treated with SQIN-Furosemide and SQIN-Infusor. All participants will be reviewed at 2 weeks and 30 days, and followed up until 60 days.REC name
North East - York Research Ethics Committee
REC reference
22/NE/0022
Date of REC Opinion
10 Feb 2022
REC opinion
Favourable Opinion