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SUBQ-HF


Title Subcutaneous Furosemide in Acute Decompensated Heart Failure
Therapeutic Area Cardiac Failure, Heart Failure, Cardiovascular Disease, Cardiomyopathy
Principal Investigator Gordon Huggins, MD
Min Age 18 Years
Gender All
Contact Nathan Yuen
617 636-4990
More Information https://clinicaltrials.gov/ct2/show/NCT03170219

Overview

The purpose of this study is to test if sending you home early from the hospital with a furosemide pump will improve your outcome after a heart failure admission. An investigational pump and drug combination - the sc2WearPump and Furosemide Injection Solution (SCP-101, made scPharmaceuticals), will be used to provide you with the drug you need and the study will also determine if this combination product is safe. "Investigational" means that the combination pump/drug is currently being tested in research studies and is not approved by the US Food and Drug Administration (FDA) for standard medical use. Furosemide is already approved by the FDA for the treatment of heart failure, but tihs study will test a furosemide injection given under the skin using a pump (sc2Wear Pump) applied to the belly.

Study Details

Inclusion Criteria

  • 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
  • Persistent congestion despite at least 18 hours of IV therapy
  • Anticipated need for at least 24 more hours of parenteral diuretic therapy

Exclusion Criteria

  • Requirement for inotropes (other than digoxin) or mechanical support during hospitalization and/or ongoing need for other intravenous therapies beyond diuretics
  • Known allergy to furosemide and and/or known sensitivity or allergy to medical adhesive tape
  • Planned discharge to location other than home

Study Requirements

Research Visits: Study will last approximately 30 days. For those randomized to the SQ Furosemide/early discharge strategy:
  • 2 follow up visits (days 7 and 30 days). Require a blood draw of approximately 15mLs for each visit
  • 1 Lab visit day (day 2). Requires a blood draw of approximately 5mLs
  • 3 Phone call visits (days 1, 3 and 5)
For those randomized to usual care strategy:
  • 1 Lab visit day (day 2). Requires a blood draw of approximately 5mLs
  • 1 day of discharge visit. Requires a blood draw of approximately 5mLs
  • 1 follow up phone call (day 7)
  • 1 follow up clinic visit (day 30). Requires a blood draw of approximately 15mLs