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

Heart Failure Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Heart Failure

• NCT number: NCT05419115
• Study type: Interventional
• Source: NHS Greater Glasgow and Clyde
• Contact: Mark Petrie, MBChB
• Phone: 0141 330 2427
• Email: mark.petrie@glasgow.ac.uk
• Status: Recruiting
• Phase: Phase 2
• Start date: November 17, 2022
• Completion date: August 30, 2024