Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failure - A Pilot Study
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 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multicenter, randomized, open label, controlled study evaluating the effectiveness,
      and safety of the Furoscix Infusor vs continued medical therapy in patients with chronic
      heart failure and fluid overload requiring augmentation in diuretic therapy outside of acute
      care setting.

      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 provide pilot data on the effectiveness and safety to inform a pivotal trial.

        2. To inform population enrichment strategies

        3. To refine pivotal trial endpoints and analytical methods

        4. To identify operational challenges of study design

        5. To assess patient adherence, competence, and experience

        6. To familiarize staff and patients with device application and use
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects are eligible for inclusion only if all the following criteria are met:

          1. Age 18 years or older.

          2. Diagnosis of symptomatic chronic heart failure (NYHA Class II-IV) with background loop
             diuretic therapy for at least 4 weeks.

          3. Need for augmented diuresis outside of the acute care setting as determined by the
             investigator.

          4. On background therapy including daily total furosemide equivalent dose (40-160 mg) of
             loop diuretic or equivalent.

          5. The subject must have signs of volume expansion, defined as two or more of the
             following six signs:

               1. jugular venous distention

               2. edema (≥ 1+)

               3. ascites

               4. pulmonary congestion on chest x-ray

               5. pulmonary rales

               6. NT-proBNP ≥1000 pg/ml (1400 for patients in atrial fibrillation) or, for patients
                  not on Entresto, BNP ≥200 (400 for patients in atrial fibrillation)

          6. Increase over the preceding 30 days in at least one of the following symptoms
             characteristic of worsening heart failure:

               1. dyspnea

               2. fatigue

               3. exercise intolerance

          7. Adequate environment for at home administration of Furoscix by patient or caregiver.

        Exclusion Criteria:

        A Subject is not eligible for inclusion if any of the following criteria apply:

          1. Suspected high risk clinical instability with outpatient treatment.

          2. Presence of a complicating condition, other than heart failure likely to require
             hospitalization in next 30 days.

          3. Pregnant women or women of childbearing age who are not willing to use an adequate
             form of contraception.

          4. Known allergy to the active and inactive ingredients of the study medication or device
             adhesive.

          5. On experimental medication or currently participating in another interventional
             research study.

          6. eGFR < 20

          7. Serum potassium at baseline > 5.4 or < 3.6

          8. Concomitant infection

          9. Heart rate > 110

         10. Received IV furosemide or bumetanide within last 24 hours