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Using a new subcutaneous furosemide to help patients with heart failure leave the hospital earlier

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

Phase 2 Interventional NHS Greater Glasgow and Clyde · NCT05419115

This study tests if a new home treatment using a patch to deliver furosemide can help people with heart failure leave the hospital sooner and stay healthy.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment170 (estimated)
Ages18 Years and up
SexAll
SponsorNHS Greater Glasgow and Clyde Academic / other
Locations22 sites (Aylesbury, England and 21 other locations)
Trial IDNCT05419115 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of a novel subcutaneous formulation of furosemide (SQIN-Furosemide) delivered at home, compared to traditional intravenous furosemide administered in the hospital, for patients with heart failure. The goal is to determine if this approach can increase the number of days patients spend alive and out of the hospital within 30 days of treatment. Participants will be monitored for safety and efficacy as they transition from hospital to home care using a small patch pump for medication delivery. The study aims to address the frequent hospitalizations associated with heart failure by facilitating early supported discharge.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with heart failure who have recently received intravenous diuretics.

Not a fit: Patients who are unable to consent or do not have a suitable home environment for treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce hospital stays for heart failure patients, improving their quality of life and reducing healthcare costs.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving patient outcomes through early discharge strategies.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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

Where this trial is running

Aylesbury, England and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart Failure
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.