Furoscix Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure (FREEDOM-HF)
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
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
- 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
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
- 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
Sites / Locations
- Olive View - UCLA Medical Center
- Bridgeport Hospital
- Tampa General Hospital
- Ascension St. Vincent Heart Center
- Unity Point Health
- University of Minnesota Medical Center
- Moses H. Cone Memorial Hospital
- Abington Hospital - Jefferson Health
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Furoscix Infusor Prospective Treatment
Propensity-Matched Historical Control
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor outside the hospital.
The control arm will be populated with claims data for patients with HF and fluid overload who presented to the emergency department and were admitted to the hospital for ≤ 72 hours for the treatment of HF with intravenous diuretics. Patients admitted for diuresis-only will be identified by using diagnostic codes for admittance from a claims database.