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

Completed · Phase 2

Conditions studied: Heart Failure

In brief

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

Key facts

Study ID

NCT04593823

Run by

scPharmaceuticals, Inc.

People needed

63

Starts

2021-05-03

Expected to finish

2022-04-18

Last updated by the study team

2023-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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+)
• ascites
• pulmonary congestion on chest x-ray
• pulmonary rales
• 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:
• dyspnea
• fatigue
• exercise intolerance
• Adequate environment for at home administration of Furoscix by patient or caregiver.

You may not qualify if…

• 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
• Concomitant infection
• Heart rate > 110
• Received IV furosemide or bumetanide within last 24 hours

Where it is running

• Heart Group of Eastern Shore — Fairhope, Alabama, United States
• The Heart Center Research, LLC — Huntsville, Alabama, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Aventura Clinical Research, LLC — Aventura, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Elite Cardiac Research — Hialeah, Florida, United States
• First Coast Cardiovascular Institute — Jacksonville, Florida, United States
• Cardiology Consultants — Pensacola, Florida, United States
• James A. Haley Veerans Hospital — Tampa, Florida, United States
• University Hospital - Augusta — Augusta, Georgia, United States
• Advocate Health and Hospitals — Downers Grove, Illinois, United States
• UnityPoint Health - Methodist Hospital — Peoria, Illinois, United States
• Michigan Heart — Ypsilanti, Michigan, United States
• St. Louis Heart and Vascular — St Louis, Missouri, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Cone Health Medical Group — Greensboro, North Carolina, United States
• Lancaster General Hospital — Lancaster, Pennsylvania, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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