Phase 3
N=40
Sub-Q Versus IV Furosemide in Acute Heart Failure
Congestive Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT02579057 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcome: Primary: Urine Output — 1636; 1515 mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Furosemide Injection Solution (SCP-101) (Drug); Furosemide Injection Solution, USP (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Jun 2017
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 | — |
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.
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). 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.