New wearable pump could send heart failure patients home early
NCT ID NCT05419115
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tested whether a new wearable pump that delivers a water pill (furosemide) under the skin could help heart failure patients leave the hospital earlier. 172 adults admitted for heart failure were randomly assigned to either go home with the pump or stay in the hospital for standard IV treatment. The main goal was to see if the home group spent more days alive and out of the hospital within 30 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- furosemide (a water pill) given under the skin via a wearable pump
- What this could lead to
- If it works, this could allow heart failure patients to finish their treatment at home instead of in the hospital, improving comfort and freeing up hospital beds.
- What could go wrong
- This is a small, early-phase trial (172 people) testing a new device and drug formulation. The device is not yet approved, and the approach may not prove safe or effective enough for routine use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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172 people
The number who actually took part.
- Started
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Nov 2022
- Finished
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Mar 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Basildon University Hospital
Basildon, England, SS16 5NL, United Kingdom
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Blackpool Victoria Hospital
Blackpool, England, FY3 8NR, United Kingdom
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Forth Valley Hospital
Larbert, Scotland, FK5 4WR, United Kingdom
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Glasgow Royal Infirmary
Glasgow, Scotland, G12 8TA, United Kingdom
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Glenfield Hospital
Leicester, England, LE3 9QP, United Kingdom
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Leeds General Infirmary
Leeds, England, LS1 3EX, United Kingdom
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Manchester Heart Centre
Manchester, England, M13 9WL, United Kingdom
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Ninewells Hospital
Dundee, Scotland, DD1 9SY, United Kingdom
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Queen Alexandra Hospital
Portsmouth, England, PO6 3LY, United Kingdom
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Queen Elizabeth University Hospital
Glasgow, Strathclyde, G51 4TF, United Kingdom
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Southmead Hospital
Bristol, England, BS10 5NB, United Kingdom
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St Thomas' Hospital
London, England, SE1 7EH, United Kingdom
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St. George's University of London
London, England, SW17 0RE, United Kingdom
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Stoke Mandeville Hospital
Aylesbury, England, HP21 8AL, United Kingdom
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Sunderland Royal Hospital
Sunderland, England, SR4 7TP, United Kingdom
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The Great Western Hospital
Swindon, United Kingdom, SN3 6BB, United Kingdom
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University Hospital Ayr
Ayr, Scotland, KA6 6DX, United Kingdom
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University Hospital Monklands
Airdrie, ML6 0JS, United Kingdom
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University Hospital Southampton
Southampton, United Kingdom
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University Hospital of North Tees
Hardwick, England, TS19 8PE, United Kingdom
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University Hospitals Dorset
Bournemouth, England, BH7 7DW, United Kingdom
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Wycombe General Hospital
High Wycombe, England, HP11 2TT, United Kingdom
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Other studies related to the condition(s) this trial covers.
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