Sub-Q Versus IV Furosemide in Acute Heart Failure
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study evaluates the clinical efficacy of subcutaneously administered Furosemide
      Injection Solution versus intravenous administration of Furosemide Injection, United States
      Pharmacopeia (USP) in adult patients presenting to a heart failure clinic with decompensated
      heart failure. Half of the patients will receive a subcutaneously administered Furosemide
      Injection Solution; the other half will receive an intravenous administration of Furosemide
      Injection.
    

Detailed description: 
      The prevalence of chronic heart failure is increasing, and despite advances in the treatment
      of chronic heart failure, in-hospital mortality and readmission are high. Heart failure costs
      the US about 32 billion per year, and a large percentage of the costs are due to
      hospitalizations. Most clinicians would agree that patients with decompensated heart failure
      presenting with hypotension, worsening renal function and altered mental status should be
      hospitalized. However, there is a subset of patients presenting with dyspnea and edema due to
      volume overload that necessitate rapid symptom improvement but are hemodynamically stable.
      Oral diuretics would likely be ineffective but hospital admission for IV diuretics seems
      excessive.

      The research hypothesis is that subcutaneously administered furosemide will be an effective
      alternative to IV furosemide for hemodynamically stable chronic heart failure patients
      presenting with volume overload in the ambulatory setting. Patients will be randomized to
      receive Furosemide Injection, USP intravenously or Furosemide Injection Solution (SCP-101)
      delivered subcutaneously. The IV patients will get the usual care of the heart failure
      clinic, which includes having an IV placed and delivery of a one-time dose of IV furosemide
      with the dose determined by the providers (maximum dose 160mg IV). The subcutaneous patients
      will receive 80mg of Furosemide Injection Solution (SCP-101) administered subcutaneously over
      5 hours (30mg in first hour and 12.5mg/hour for 4 hours).

      Both groups of patients will be observed for 6 hours to assess diuresis. Patients will be
      asked to fill out a survey about their symptom improvement (Kansas City Cardiomyopathy
      questionnaire) and overall satisfaction related to the treatment experience. They will also
      be monitored for side effects including ototoxicity and discomfort at the access site
      (burning, itching, and pain). Electrolytes and renal function will be checked once after the
      patients receive diuretic therapy.
    

Intervention name(s): Furosemide Injection Solution (SCP-101); Furosemide Injection Solution, USP
Intervention type(s): Drug; Drug
Other intervention name(s): sc Furosemide; IV furosemide
Intervention MeSH terms: Furosemide; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Congestive heart failure; Furosemide