Furoscix Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure (NCT03458325) | Clinical Trial Compass
CompletedPhase 3
Furoscix Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure
United States27 participantsStarted 2020-11-12
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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