Subcutaneous Furosemide in Acute Decompensated Heart Failure Pilot

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Margaret Redfield, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
.
CLS-20271974

Mayo Clinic Footer