Ensayos clínicos

Inclusion Criteria:

• Age >18 years
• Willingness and ability to provide informed consent
• 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

• 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
• Total anticipated daily IV furosemide dose (at time of screening) >80-200 mg (or equivalent)/day
• Anticipated need for at least 24 more hours of parenteral diuretic therapy

Exclusion Criteria:

• Severe renal dysfunction (Estimated Glomerular Filtration Rate (eGFR)< 30 ml/min/1.73m2)
• Requirement for inotropes (other than digoxin) or mechanical support during hospitalization
• Clinically significant electrical instability during hospitalization
• Ongoing need for other intravenous therapies beyond diuretics (vasodilators, antibiotics, etc.)
• Anticipated need for ongoing parenteral electrolyte repletion
• Planned discharge to location other than home (e.g, hospice, skilled nursing facility, etc.)
• Anticipated cardiac transplantation or left ventricular assist device within the next 30 days
• Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, acute myocarditis, constrictive pericarditis or tamponade
• 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
• Other psychosocial or physical barriers to following the protocol and using a subcutaneous pump device outside the hospital setting
• Unable to accurately measure urine output
• Known allergy to furosemide
• Known sensitivity or allergy to medical adhesive tape