Impact of at-home subcutaneous furosemide in heart failure patients with chronic kidney disease on prevention of hospital admission: a randomised controlled, feasibility trial
Heart failure with chronic kidney disease, with fluid overload
The trial will be delivered in two stages. Patients recruited in stage 1 will be randomised to stage 2 if they develop fluid overload. Stage 1 is a follow-up study of 200 patients of heart failure with stable chronic kidney disease and recent hospital admission. In stage 1 patients will be screened and consented for both stages of the trial after been provided with information on follow-up and novel drug and device therapy in stage 2. Once recruited they will have baseline data collected and followed up with regular (two-monthly) phone calls. Once they report fluid overload either during the phone call or by themselves, they will be recruited into stage two. Stage 2 is an open label randomised controlled trial of management of fluid overload in stage 1 patients once they have developed fluid overload. Once screened with specific inclusion/exclusion criterion the eligible (stable) patients will be recruited to stage 2. Patients will be randomised at a 1:1 ratio using an online tool to either at home 5-day course of 80mg subcutaneous furosemide daily using a novel device or standard care. The standard care for most patients will be an emergency room visit and hospital admission or dose escalation with diuretics by their usual physician. The regular medications will be unchanged. The home care patients will have daily phone calls and home visits during the five days. They will also have blood tests done twice between day 2 and 5. At any time if patient becomes unwell they will be able to be attend emergency room and get admitted into hospital. The patients will self-monitor their vitals (weight, blood pressure, pulse, oxygen saturation) daily during the five days. The patients will have blood tests, breathlessness scores, quality of life score and urine sodium done at day 1 and day 6 of the second stage. The standard care patients will have their data collected from hospital records with phone calls as required. Patients would be followed up on the following outcome
Stage 1: 1. Age ≥18 years 2. Established HF diagnosis 3. Established CKD with stable eGFR < 60 ml/min/1.73m2 4. Hospital admission within previous twelve months 5. Able to provide informed written consent 6. Is (or has a carer who is) able and willing to administer SQIN-Furosemide with SQIN infusor at home. This will be assessed using at screening using a dummy device. 7. Is (or has a carer who is) able and willing to comply with the required monitoring at-home 8. Has a suitable home environment for the administration of SQIN-Furosemide at home Stage 2: 1. Meets inclusion criteria of stage 1 2. Weight gain of at least 5 kg from baseline weight 3. At least one sign of congestion (e.g., pitting oedema, raised jugular venous pressure, chest crepitations, pulmonary oedema on chest x-ray) 4. Established on oral loop diuretic
Current exclusion criteria as of 31/03/2026: Stage 1: 1. Established on renal replacement therapy 2. Presence of lung disease causing hypoxia 3. Uncontrolled tachyarrhythmia 4. On palliative care pathway 5. Pregnant (females of childbearing potential must have a negative pregnancy test within 7 days prior to treatment initiation) or breastfeeding 6. Hypersensitivity to the active substance or any excipient 7. Hypersensitivity to amiloride, sulphonamides, or sulphonamide derivatives Stage 2: 1. Meets any exclusion criterion in stage 1 2. Systolic blood pressure <95 mmHg 3. Oxygen saturation <95% 4. Temperature ≥39°C 5. Presence of acute kidney injury 6. Resting heart rate >100 bpm 7. New onset arrhythmia 8. Requires admission to hospital, at clinician discretion 9. Potassium <3.5 mmol/L 10. Hypersensitivity to the active substance or any excipient 11. Hypersensitivity to amiloride, sulphonamides, or sulphonamide derivatives 12. Pregnant (Pregnancy – females of childbearing potential must have a negative pregnancy test within 7 days prior to treatment initiation) or breastfeeding Previous exclusion criteria: Stage 1: 1. Established on renal replacement therapy 2. Presence of lung disease causing hypoxia 3. Uncontrolled tachyarrhythmia 4. On palliative care pathway 5. Pregnant (females of childbearing potential must have a negative pregnancy test within 7 days prior to treatment initiation) or breastfeeding Stage 2: 1. Meets any exclusion criterion in stage 1 2. Systolic blood pressure <95 mmHg 3. Oxygen saturation <95% 4. Temperature ≥39°C 5. Presence of acute kidney injury 6. Resting heart rate >100 bpm 7. New onset arrhythmia 8. Requires admission to hospital, at clinician discretion 9. Potassium <3.5 mmol/L