Use of a Novel SUBCUTaneous Preparation of Furosemide to Facilitate Early Supported Discharge of … (NCT05419115) | Clinical Trial Compass
CompletedPhase 2
Use of a Novel SUBCUTaneous Preparation of Furosemide to Facilitate Early Supported Discharge of Patients With Heart Failure
United Kingdom172 participantsStarted 2022-11-17
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 myocardia…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.