Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failure - A Pilot Study

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2021
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
Epistemonikos ID: a34d48e3006b65c194ee769702a5bd21388f65fe
First added on: May 07, 2024