Home CHF feasibility trial protocol: Impact of at-home Subcutaneous furosemide in patients with Chronic Kidney Disease and Heart Failure

Background and aim

Hospital admissions are common in patients with heart failure (HF), particularly in those with concomitant chronic kidney disease (HF-CKD). Hospitalisation is often driven by fluid overload, requiring intravenous furosemide. Subcutaneous furosemide is emerging as an alternative which may facilitate at-home treatment. This study will assess the feasibility of conducting a randomised controlled trial (RCT) to evaluate whether subcutaneous furosemide can reduce hospital admissions in people with HF-CKD.

Methods

Stage one – Recruitment and monitoring of at-risk patients: We aim to recruit 200 people with HF-CKD with at least one hospital admission within the preceding year. These participants will be monitored for signs of fluid accumulation.

Stage two - Treatment: The second stage will run contemporaneously to the first stage. The first 80 participants to develop fluid accumulation will be randomised to usual care (attend hospital and receive standard treatment) or at-home furosemide. The participants allocated to home treatment will administer SQIN-furosemide via a patch infusor device, 80 mg daily for five days, then be reviewed in a final clinic appointment. These participants will monitor their weight and observations daily, as well as receive a check-in call from the research team. Potassium levels will be checked twice over five days. The primary outcome of this feasibility study will be recruitment and retention of participants, as well as adherence to the intervention.

Discussion

Findings from this feasibility trial will inform the planning of a definitive RCT to evaluate whether subcutaneous furosemide can reduce hospital admissions in people living with HF-CKD.