Key result
Randomized trial evaluates feasibility of at-home subcutaneous furosemide for worsening heart failure with CKD.
Why the study?
Hospital admissions driven by fluid overload are common in patients with HF and concomitant CKD, and while subcutaneous furosemide is emerging as an alternative to facilitate at-home treatment, the feasibility of conducting an RCT to evaluate whether it reduces hospital admissions in this population needed assessment.
Does at-home subcutaneous furosemide improve feasibility outcomes (recruitment, retention, adherence) and reduce hospital admissions in patients with heart failure and chronic kidney disease developing fluid accumulation?
RCT (n=200)
Randomized
Does at-home subcutaneous furosemide improve feasibility outcomes (recruitment, retention, adherence) and reduce hospital admissions in patients with heart failure and chronic kidney disease developing fluid accumulation?
This trial protocol outlines a feasibility RCT evaluating whether at-home subcutaneous furosemide via a patch infusor can safely manage fluid overload and avoid hospitalization in high-risk patients with heart failure and chronic kidney disease.
Supports at-home subcutaneous furosemide for fluid overload in HF-CKD; extends feasibility data and justifies larger efficacy RCTs.
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.
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Tumelty et al. (2026) conducted an RCT in Heart failure and concomitant chronic kidney disease (HF-CKD) (n=200). At-home subcutaneous furosemide (SQIN-furosemide via patch infusor device) vs. Usual care (attend hospital and receive standard treatment) was evaluated on Recruitment and retention of participants, as well as adherence to the intervention. At-home subcutaneous furosemide (80 mg/day for 5 days) vs usual care is being evaluated for feasibility in 200 monitored (80 randomized) HF-CKD patients (trial protocol, no results yet).
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