Phase 1 N=40 Treatment

Subcutaneous Furosemide in Acute Decompensated Heart Failure Pilot

Acute Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT02877095 ↗

Enrolled (actual)

Serious AEs

2.5%

Results posted

Mar 2019

Primary outcome: Primary: Overall Safety of a Strategy Based on Subcutaneous Delivery of Furosemide in Inpatients and Outpatients as Measured by Number of Adverse Events — 4; 9; 16; 11 participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Furosemide (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Adrian Hernandez
Primary completion: Nov 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Safety of a Strategy Based on Subcutaneous Delivery of Furosemide in Inpatients and Outpatients as Measured by Number of Adverse Events	4; 9; 16; 11	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02877095). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.