Heart failure with chronic kidney disease, with fluid overload Circulatory System
Conditions
Interventions
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 wi
Sponsors
St George’s University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 100 bpm 7. New onset arrhythmia 8. Requires admission to hospital, at clinician discretion 9. Potassium 100 bpm 7. New onset arrhythmia 8. Requires admission to hospital, at clinician discretion 9. Potassium <3.5 mmol/L
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Number of participants consented to be randomised at end of stage 1, measured at the end of the trial 2.Number of participants able to complete the intervention, measured at end of trial 3.How many of the participants were able to self-administer the device during the trial, measured each day during the 5-day treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Daily weights of the participants measured daily during the 5-day treatment period 2. Breathlessness score measured daily during the 5-day treatment period 3. Urine sodium, measured twice during the 5-day treatment period 4. Quality of life, measured using the EQ-5D-5L quality of life scale, at Day 0 and Day 6 of Stage 2 of the trial 5. NTproBNP, measured using serum blood tests twice during the 5-day treatment period 6. Hospital admissions, measured at day-30 after trial completion 7. Device ease of use, measured with device usability scale each day during the 5-day treatment period | — |
Countries
United Kingdom
Contacts
Public ContactDebasish Banerjee
Outcome results
None listed