Subcutaneous Furosemide in Acute Decompensated Heart Failure Pilot
Condition: Acute Heart Failure
MeSH terms: Heart Failure
Intervention: Furosemide
Intervention description: subcutaneous furosemide delivered via subcutaneous pump
Intervention MeSH terms: Furosemide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The Pilot study is designed to evaluate the overall safety and feasibility of a strategy
      based on subcutaneous delivery of furosemide. It will be used to inform the subsequent
      evaluation phase of the study (separate protocol). The primary objective of the study is to
      determine if a strategy of a novel subcutaneous delivery of furosemide is safe and feasible
      in patients with acute heart failure.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age >18 years

          2. Willingness and ability to provide informed consent

          3. Hospitalization for acute heart failure (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, Brain Natriuretic Peptide > 250
             ng/mL or N-terminal pro-brain natriuretic peptide (NTproBNP) > 1000 ng/mL) of
             congestion

          4. Persistent congestion despite at least 18 hours of intravenous (IV) therapy, defined
             by the presence of at least 2 or more of the following at the time of consent:

               -  Peripheral edema

               -  Rales

               -  Elevated jugular venous pressure (JVP)

               -  Ascites

               -  BNP > 250 ng/mL or NTproBNP > 1000 ng/mL

          5. Total anticipated daily IV furosemide dose (at time of screening) >80-200 mg (or
             equivalent)/day

          6. Anticipated need for at least 24 more hours of parenteral diuretic therapy -

        Exclusion Criteria:

          1. Severe renal dysfunction (Estimated Glomerular Filtration Rate (eGFR)< 30
             ml/min/1.73m2)

          2. Requirement for inotropes (other than digoxin) or mechanical support during
             hospitalization

          3. Clinically significant electrical instability during hospitalization

          4. Ongoing need for other intravenous therapies beyond diuretics (vasodilators,
             antibiotics, etc.)

          5. Anticipated need for ongoing parenteral electrolyte repletion

          6. Planned discharge to location other than home (e.g, hospice, skilled nursing facility,
             etc.)

          7. Anticipated cardiac transplantation or left ventricular assist device within the next
             30 days

          8. Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, acute myocarditis,
             constrictive pericarditis or tamponade

          9. Known or anticipated pregnancy in the next 30 days Prior use of 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 a
             subcutaneous pump device outside the hospital setting

         11. Unable to accurately measure urine output

         12. Known allergy to furosemide

         13. Known sensitivity or allergy to medical adhesive tape