Heart Failure Clinical Trial
Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failure – A Pilot Study
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:
To provide pilot data on the effectiveness and safety to inform a pivotal trial.
To inform population enrichment strategies
To refine pivotal trial endpoints and analytical methods
To identify operational challenges of study design
To assess patient adherence, competence, and experience
To familiarize staff and patients with device application and use
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. 51 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.
Subjects are eligible for inclusion only if all the following criteria are met:
Age 18 years or older.
Diagnosis of symptomatic chronic heart failure (NYHA Class II-IV) with background loop diuretic therapy for at least 4 weeks.
Need for augmented diuresis outside of the acute care setting as determined by the investigator.
On background therapy including daily total furosemide equivalent dose (40-160 mg) of loop diuretic or equivalent.
The subject must have signs of volume expansion, defined as two or more of the following six signs:
jugular venous distention
edema (≥ 1+)
pulmonary congestion on chest x-ray
NT-proBNP ≥1000 pg/ml (1400 for patients in atrial fibrillation) or, for patients not on Entresto, BNP ≥200 (400 for patients in atrial fibrillation)
Increase over the preceding 30 days in at least one of the following symptoms characteristic of worsening heart failure:
Adequate environment for at home administration of Furoscix by patient or caregiver.
A Subject is not eligible for inclusion if any of the following criteria apply:
Suspected high risk clinical instability with outpatient treatment.
Presence of a complicating condition, other than heart failure likely to require hospitalization in next 30 days.
Pregnant women or women of childbearing age who are not willing to use an adequate form of contraception.
Known allergy to the active and inactive ingredients of the study medication or device adhesive.
On experimental medication or currently participating in another interventional research study.
eGFR < 20
Serum potassium at baseline > 5.4 or < 3.6
Heart rate > 110
Received IV furosemide or bumetanide within last 24 hours
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There are 18 Locations for this study
Fairhope Alabama, 36532, United States
Huntsville Alabama, 35801, United States
Hartford Connecticut, 06102, United States
Aventura Florida, 33541, United States
Gainesville Florida, 32611, United States
Hialeah Florida, 33012, United States
Jacksonville Florida, 32256, United States
Pensacola Florida, 32501, United States
Tampa Florida, 33612, United States
Augusta Georgia, 30901, United States
Downers Grove Illinois, 60515, United States
Peoria Illinois, 61606, United States
Ypsilanti Michigan, 48197, United States
Saint Louis Missouri, 63136, United States
New York New York, 10029, United States
Greensboro North Carolina, 27455, United States
Lancaster Pennsylvania, 17602, United States
Madison Wisconsin, 53792, United States
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