Furoscix Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      This adaptive clinical trial will include 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. Eligible patients for the Furoscix arm will be patients with HF and fluid
      overload who initially present to the emergency department (ED) and who are expected to
      require parenteral diuresis.

      If it is determined by the investigator that the patient requires parenteral diuresis or
      continued diuresis outside of the ED care setting and meets all study eligibility criteria,
      he/she may be consented and enrolled into the study.

      The treatment comprises a preprogrammed bi-phasic 5-hour drug administration. Subjects will
      be instructed on the use of the Furoscix Infusor by the investigator and/or study staff in
      accordance with the instructions for use. The initial dose of the study product may be
      administered in the ED or at home. Additional doses will be provided to the subject for
      self-administration or administration by a caregiver in the home setting as directed by the
      investigator or study staff. The total duration in days and total number of doses of the
      initial therapy will be determined by the investigator based on an estimated volume of
      diuresis desired to transition patient back to their oral diuretic maintenance therapy.
      Subjects will receive scheduled at-home telephone calls from a HF nurse on Days 1 and 7 and
      one call between Days 14-21. Planned in-clinic visits will be conducted between Day 2-4 and
      then Day 30. Unscheduled at-home telephone calls by a HF nurse and unscheduled in-clinic
      visits may be performed if felt clinically indicated by the study team or the clinical
      provider.

      The study period will be up to 30 days after enrollment. All outcomes will be assessed up to
      30 days after the initial discharge from the emergency department.
    

Intervention name(s): Furoscix Infusor
Intervention type(s): Combination Product
Intervention description(s): 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.
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)
Primary purpose: Treatment