Sub-Q Versus IV Furosemide in Acute Heart Failure

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: scPharmaceuticals, Inc.
• Treatments: Furosemide; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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