Furoscix Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure

Completed · Phase 3

Conditions studied: Heart Failure

In brief

The study is to evaluate the safe admission avoidance and the overall economic impact associated with management of worsening HF using the drug-device combination product, the Furoscix Infusor, outside the hospital setting in patients initially presenting to the emergency department. 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 evaluate differences in healthcare resource utilization and direct medical costs for patients treated with the Furoscix Infusor outside the hospital versus patients receiving intravenous furosemide for ≤ 72 hours in the hospital setting for 30 days post-discharge from the emergency department. 2. To evaluate the safety of Furoscix administered outside the hospital. 3. To evaluate and describe quality of life and patient satisfaction for patients who receive the Furoscix Infusor outside the hospital setting.

Key facts

Study ID

NCT03458325

Run by

scPharmaceuticals, Inc.

People needed

27

Starts

2020-11-12

Expected to finish

2021-06-24

Last updated by the study team

2023-02-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-80 years
• NYHA Class II-III HF presenting to the emergency department for worsening HF at baseline
• On background therapy includes those receiving 40-160 mg of oral furosemide equivalents daily (20-80 mg Torsemide or 1-4 mg Bumetanide).
• Signs of extracellular volume expansion, defined as one or more of the following:
• jugular venous distention
• pitting edema (≥1+),
• abdominal distension
• pulmonary congestion on chest x-ray
• pulmonary rales
• After initial emergency department evaluation and treatment (i.e., at the time of the care transition decision*), candidates for parenteral diuresis outside of the hospital, defined as all the following:
• Oxygen saturation ≥ 90% on exertion
• Respiratory Rate < 24 breaths per minute
• Resting Heart Rate < 100 beats per minute
• Systolic Blood Pressure > 100 mmHg
• Adequate environment for at-home administration of Furoscix

You may not qualify if…

• Presence of a complicating condition, other than HF that requires immediate hospitalization or anticipated hospitalization in the next 30 days
• Evidence of acute renal failure as determined at the discretion of the investigator
• Known allergy to the active and inactive ingredients of the study medication or device adhesive
• Any local abdominal skin condition on the day of treatment i.e. sunburn, rash, eczema, etc.
• Currently participating in another interventional research study
• Women who are pregnant or who could become pregnant and are not willing to use an adequate form of contraception
• Estimated Creatinine Clearance < 30 mL per minute by Cockcroft-Gault equation
• CrCl (mL/min) = {(140 - age) x Lean Body Weight (kg)/Serum Creatinine (mg/dL) x 72} (x 0.85 if female)
• If baseline creatinine value is available: an increase of ≥ 0.5 mg/dL in creatinine from baseline
• HF requiring immediate hospitalization

Where it is running

• Olive View - UCLA Medical Center — Sylmar, California, United States
• Bridgeport Hospital — Bridgeport, Connecticut, United States
• Tampa General Hospital — Tampa, Florida, United States
• Ascension St. Vincent Heart Center — Indianapolis, Indiana, United States
• Unity Point Health — Des Moines, Iowa, United States
• University of Minnesota Medical Center — Minneapolis, Minnesota, United States
• Moses H. Cone Memorial Hospital — Greensboro, North Carolina, United States
• Abington Hospital - Jefferson Health — Abington, Pennsylvania, United States

Full record on ClinicalTrials.gov

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