Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failure - A Pilot Study
Summary
This is a multicenter, randomized, open label, controlled study evaluating the effectiveness, and safety of the Furoscix Infusor vs continued medical therapy in patients with chronic heart failure and fluid overload requiring augmentation in diuretic therapy outside of acute care setting. The study drug, Furoscix (furosemide injection 8 mg/ml), is a furosemide solution buffered to a neutral pH containing 80 mg/10 mL for subcutaneous administration over 5 hours via the Furoscix Infusor. The study objectives are: 1. To provide pilot data on the effectiveness and safety to inform a pivotal trial. 2. To inform population enrichment strategies 3. To refine pivotal trial endpoints and analytical methods 4. To identify operational challenges of study design 5. To assess patient adherence, competence, and experience 6. To familiarize staff and patients with device application and use
Timeline
- Start
- 2021-05-03
- Primary completion
- 2022-04-18
- Completion
- 2022-04-18
Outcome
Missed primary endpoint
paper The composite primary endpoint was not statistically significant in this pilot investigation. PMID 39269392 ↗
paper SC furosemide-to-UC win ratio was 1.11 (95% CI: 0.48-2.50; P = 0.806). PMID 39269392 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Furosemide | Other / unclassified | 80 mg | Subcutaneous |