Sub-Q Versus IV Furosemide in Acute Heart Failure

Completed · Phase 2/Phase 3

Conditions studied: Congestive Heart Failure

In brief

This study evaluates the clinical efficacy of subcutaneously administered Furosemide Injection Solution versus intravenous administration of Furosemide Injection, United States Pharmacopeia (USP) in adult patients presenting to a heart failure clinic with decompensated heart failure. Half of the patients will receive a subcutaneously administered Furosemide Injection Solution; the other half will receive an intravenous administration of Furosemide Injection.

Key facts

Study ID

NCT02579057

Run by

Johns Hopkins University

People needed

40

Starts

2016-02-01

Expected to finish

2017-07-01

Last updated by the study team

2017-12-18

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
• Male and female subjects > 18 years of age
• History of at least 3 months treated heart failure (NYHA class II/III/IV), or recent hospitalization for heart failure; presenting to Heart Failure Bridge Clinic (HFBC) with decompensated heart failure symptoms including elevated jugular venous pressure, dyspnea and peripheral edema where the decision is made to give IV diuretics
• Able to participate in the study in the opinion of the investigator
• Has the ability to understand the requirements of the study and is willing to comply with all study procedures

You may not qualify if…

• Presenting with symptoms where it is anticipated that there is a high chance of hospitalization such as ischemia, uncontrolled arrhythmia, infection, hemodynamic instability (elevated or low blood pressure), respiratory compromise, or electrolyte abnormalities (>25% increase in creatinine from baseline, potassium, hyponatremia).
• On experimental medication or currently participating in a cardiovascular research study.
• Presence or need for urinary catheterization, urinary tract abnormality or disorder interfering with urination
• Any surgical or medical condition which in the opinion of the investigator may interfere with participation in the study or which may affect the outcome of the study
• Inability to comply with study requirements

Where it is running

• Johns Hopkins Hospital Heart Failure Bridge Clinic — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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