Furoscix Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Furoscix Infusor
Intervention description: Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: A prospective treatment arm (i.e., Furoscix administered via the Furoscix Infusor) administered outside the hospital that will be compared to a propensity-matched historical control arm of patients admitted to the hospital for ≤ 72 hours (i.e., Treatment As Usual (TAU)) that will be derived from administrative claims data.
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18-80 years

          2. NYHA Class II-III HF presenting to the emergency department for worsening HF at
             baseline

          3. On background therapy includes those receiving 40-160 mg of oral furosemide
             equivalents daily (20-80 mg Torsemide or 1-4 mg Bumetanide).

          4. Signs of extracellular volume expansion, defined as one or more of the following:

               1. jugular venous distention

               2. pitting edema (≥1+),

               3. abdominal distension

               4. pulmonary congestion on chest x-ray

               5. pulmonary rales

          5. 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:

               1. Oxygen saturation ≥ 90% on exertion

               2. Respiratory Rate < 24 breaths per minute

               3. Resting Heart Rate < 100 beats per minute

               4. Systolic Blood Pressure > 100 mmHg

          6. Adequate environment for at-home administration of Furoscix

        Exclusion Criteria:

          1. Presence of a complicating condition, other than HF that requires immediate
             hospitalization or anticipated hospitalization in the next 30 days

          2. Evidence of acute renal failure as determined at the discretion of the investigator

          3. Known allergy to the active and inactive ingredients of the study medication or device
             adhesive

          4. Any local abdominal skin condition on the day of treatment i.e. sunburn, rash, eczema,
             etc.

          5. Currently participating in another interventional research study

          6. Women who are pregnant or who could become pregnant and are not willing to use an
             adequate form of contraception

          7. 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)

          8. If baseline creatinine value is available: an increase of ≥ 0.5 mg/dL in creatinine
             from baseline

          9. HF requiring immediate hospitalization