Phase 3
Completed N=40
Sub-Q Versus IV Furosemide in Acute Heart Failure
Source: ClinicalTrials.gov NCT02579057 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcomePrimary: Urine Output — 1636; 1515 mL
◆ Published Evidence
Emerging
10citations · ~1 / year
Efficacy of Intravenous Furosemide Versus a Novel, pH-Neutral Furosemide Formulation Administered Subcutaneously in Outpatients With Worsening Heart Failure.
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.
Linked Publications
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Efficacy of Intravenous Furosemide Versus a Novel, pH-Neutral Furosemide Formulation Administered Subcutaneously in Outpatients With Worsening Heart Failure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urine Output |
1636; 1515 | — |
| SECONDARY Heart Failure Symptom Scoring/Symptom Improvement |
— | — |
| SECONDARY Number of Participants With Side Effects |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Urine Sodium |
7.3; 32.8 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02579057) and the linked publication. 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. Informational only — not medical advice.