Impact of at-home subcutaneous furosemide in heart failure patients with chronic kidney disease on prevention of hospital admission; a randomised controlled, feasibility trial

Background Heart failure (HF) is a common cause for hospital admissions, particularly in elderly and increasing in prevalence.

Hospital admissions to treat fluid overload, using intravenous furosemide, are common in HF; associated with infection, long length of stay and mortality; and half may be avoidable with a safe and effective alternative. They are even more common in the 50% of patients with HF who also have chronic kidney disease (HF-CKD).

At-home subcutaneous furosemide (as we have done in a service-improvement project), with a novel wearable device may be a safe alternative.

Aims and objectives We propose to test in a randomised study if subcutaneous, pH neutral SQIN-furosemide delivered via novel wearable SQIN-infusor device can be safely used at-home to treat fluid overload in HF-CKD patients compared to usual care.

The aim of this feasibility study is to find out if it s possible to run a large randomised controlled trial testing whether this method compared to usual care can reduce hospital admissions and death in HF-CKD patients.

Feasibility will be assessed by the number of patients who consent, the acceptability of the intervention, and patient adherence.

Exploratory outcomes will include number of hospitalisations and adverse events in each group, as well as changes in weight and dyspnoea score.

Methods: Stage 1 – Recruitment of at-risk patients: HF-CKD patients with a hospital admission in the preceding 12 months will be approached, with an aim of recruiting 200.

When recruited, patients will have baseline bloods taken, be educated on recognising fluid accumulation, and given contact details to contact if/when they develop symptoms and signs of fluid accumulation. Each patient will receive a check-in telephone call from the team, every two months. Stage 2 - Treatment: This will run alongside the first stage.

The first 80 patients to develop fluid accumulation will be randomised to usual care or at-home furosemide.

Patients allocated to home treatment will themselves administer the SQIN-furosemide via the abdominal-patch pump (9.3cmx5cmx2.2cm), 80mg daily, at a rate of 30mg in the first hour followed by 12.5mg per hour for four hours, for a total of five days. Patients will monitor their observations and weight and will receive a daily check-in call from the team.

Potassium levels will be checked twice during the five days, and supplements provided accordingly. Patients allocated to usual care will attend hospital and receive standard treatment. We will assess all patients at the end of the 5 days at a final clinic appointment. Timelines for delivery This study will run over three years.

If subcutaneous furosemide is safe and acceptable, the definitive trial will follow, which will run over 3.5-years.

Anticipated impact and dissemination The findings will be presented at conferences, published in open-access journal, and shared with patient groups and social media. A local patient engagement/information event will be held.

A lay publication will be written in collaboration with members of our PPI advisory group to ensure wide access of our findings.