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

Summary

Participation Requirements

Description

The purpose of this study is to evaluate 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. Up to 50 patients will be randomly assigned (...

The purpose of this study is to evaluate 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. Up to 50 patients will be randomly assigned (2:1) to receive Furoscix vs continued medical therapy. The Treatment Phase comprises a pre-programmed bi-phasic 5-hour drug administration of Furoscix (80 mg/10 mL) via the On-body Infusor. Subjects and/or their caregivers will be trained on device preparation, placement and removal in accordance with product instructions of use (IFU). Subjects should be transitioned back to their oral maintenance diuretic regimen when clinically indicated at the discretion of the investigator. Over the initial 7 days, all subjects will receive daily clinic or phone follow-up by the study staff. Decision of treatment with Furoscix in the intervention arm as well as changes in oral diuretic dosing in the control arm will be determined by the treating physician in coordination with the study nurse. Safety labs will be done on Days 1, 3, 7 and 30. After Subjects have been transitioned to their oral maintenance diuretic regimen, additional doses of Furoscix (for Furoscix group) or IV diuretics (for Treat as Usual group) can be prescribed during the 30-day study period as needed based on the presence of congestion symptoms (e.g. dyspnea, edema, and/or excess weight gain) as determined by the investigator. The Follow-Up Phase will include a visit to the clinic on Day 30 +/- 5 days where effectiveness and safety assessments will be performed including limited physical exam (including NYHA Class), Composite Congestion Score (CCS), 5-point Current Dyspnea Score, 7-point Dyspnea Score, vital signs, laboratory analyses, KCCQ-12, Visual Analog Score (VAS), 6MWT and adverse events.

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