Subcutaneous Furosemide in Acute Decompensated Heart Failure Pilot

Description

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.

Study Start Date

December, 19 2016

Estimated Completion Date

December 2017

Interventions

  • Drug: Furosemide

Study ID

Duke University -- Pro00070399

Status

Recruiting

Trial ID

NCT02877095

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

40

Sponsor

Duke University

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

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (10)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Metro Health System - Cleveland, Ohio 544.9 miles None None None
Metro Health System - Cleveland, Ohio 544.9 miles None None None
Metro Health System - Cleveland, Ohio 544.9 miles None None None
Duke University Medical Center - Durham, North Carolina 608.4 miles None None None
Duke University Medical Center - Durham, North Carolina 608.4 miles None None None
Emory University Hospital - Atlanta, Georgia 932.0 miles None None None
Mayo Clinic - Rochester, Minnesota 1,083.1 miles None None None
Mayo Clinic - Rochester, Minnesota 1,083.1 miles None None None

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