Subcutaneous Furosemide in Acute Decompensated Heart Failure: The SUBQ-HF Study
Condition: Acute Heart Failure; Decompensated Heart Failure
MeSH terms: Heart Failure
Intervention: subcutaneous furosemide and sc2wear device
Intervention description: subcutaneous furosemide administered via sc2wear device vs. standard of care
Intervention MeSH terms: Furosemide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To determine if a strategy of early discharge using a novel subcutaneous delivery system for
      parenteral furosemide can improve clinical outcomes within 30 days of randomization (days
      alive and outside the hospital) compared to usual care.
    

Eligibility criteria:

        Inclusion Criteria for Pathway 1 (patients hospitalized with acute heart failure)

          1. Age >18 years

          2. Willingness and ability to provide informed consent

          3. Hospitalization for AHF with at least 1 symptom (dyspnea, orthopnea, or edema) AND 1
             sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion
             on chest radiography, BNP > 250 ng/mL or NTproBNP > 1000 ng/mL) of congestion

          4. Persistent congestion defined by the presence of at least 2 or more of the following
             at the time of consent:

               1. Peripheral edema

               2. Rales

               3. Elevated JVP

               4. Ascites

               5. BNP > 250 ng/mL or NTproBNP > 1000 ng/mL during index hospitalization

               6. Orthopnea

          5. Total anticipated daily IV furosemide dose (at time of screening) >80-240 mg (or
             equivalent)/day

          6. Anticipated need for at least 24 more hours of parenteral diuretic therapy

        Exclusion Criteria for Pathway 1

          1. Severe renal dysfunction (eGFR< 20 ml/min/1.73m2) within 24 hours of enrollment

          2. Requirement for inotropes (other than digoxin) or mechanical support during
             hospitalization

          3. Clinically significant electrical instability during hospitalization

          4. Anticipated need for ongoing intravenous therapies beyond diuretics (electrolyte
             repletion, vasodilators, antibiotics, etc.)

          5. Planned discharge to location other than home (e.g., hospice, skilled nursing
             facility, etc.)

          6. Anticipated cardiac transplantation or left ventricular assist device within the next
             30 days

          7. Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, acute myocarditis,
             constrictive pericarditis or tamponade

          8. Known or anticipated pregnancy in the next 30 days

          9. Prior use of a subcutaneous furosemide pump or current use of any subcutaneous pump,
             on-body infusion devices or patients who give regimented injections at the intended
             site of the furosemide infusion device.

         10. Other psychosocial or physical barriers to following the protocol and using SQ pump
             device outside the hospital setting

         11. Known allergy to furosemide

         12. Known sensitivity or allergy to medical adhesive tape

         13. Enrollment or planned enrollment in another therapeutic clinical trial in next 3
             months

         14. Presentation is for indication other than CHF

        Inclusion Criteria for Pathway 2 (Outpatients with heart failure presenting with volume
        overload necessitating treatment with parenteral loop diuretics)

          1. Age >18 years

          2. Willingness and ability to provide informed consent

          3. HF now presenting with volume overload defined by the presence of at least 2 or more
             of the following at the time of consent:

               1. Peripheral edema

               2. Rales

               3. Elevated JVP

               4. Ascites

               5. BNP > 250 ng/mL or NTproBNP > 1000 ng/mL during this episode of decompensation

               6. Orthopnea

          4. Need for parenteral furosemide with an estimated SQ furosemide requirement between
             80-240 mg/day

          5. Anticipated need for at least 24 hours of parenteral diuretic therapy

        Exclusion Criteria for Pathway 2

          1. Severe renal dysfunction (eGFR< 20 ml/min/1.73m2) within 24 hours of enrollment

          2. Anticipated need for inotropes (other than digoxin) or mechanical support to treat
             current episode of decompensation

          3. Clinically significant electrical instability requiring hospitalization

          4. Anticipated need for ongoing intravenous therapies beyond diuretics (electrolyte
             repletion, vasodilators, antibiotics, etc.)

          5. Residence at location other than home (e.g., hospice, skilled nursing facility, etc.)

          6. Anticipated cardiac transplantation or left ventricular assist device within the next
             30 days

          7. Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, acute myocarditis,
             constrictive pericarditis or tamponade

          8. Known or anticipated pregnancy in the next 30 days

          9. Prior use of a subcutaneous furosemide pump or current use of any subcutaneous pump,
             on-body infusion devices or patients who give regimented injections at the intended
             site of the furosemide infusion device.

         10. Other psychosocial or physical barriers to following the protocol and using SQ pump
             device outside the hospital setting

         11. Known allergy to furosemide

         12. Known sensitivity or allergy to medical adhesive tape

         13. Enrollment or planned enrollment in another therapeutic clinical trial in next 3
             months.

         14. Presentation is for indication other than CHF.