Sub-Q Versus IV Furosemide in Acute Heart Failure
Status: | Completed |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - 100 |
Updated: | 12/20/2017 |
Start Date: | February 2016 |
End Date: | July 2017 |
Prospective, Randomized, Parallel-Group Pilot Study Comparing IV Furosemide to Subcutaneous Furosemide in Acute Decompensated Heart Failure Patients
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.
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.
The prevalence of chronic heart failure is increasing, and despite advances in the treatment
of chronic heart failure, in-hospital mortality and readmission are high. Heart failure costs
the US about 32 billion per year, and a large percentage of the costs are due to
hospitalizations. Most clinicians would agree that patients with decompensated heart failure
presenting with hypotension, worsening renal function and altered mental status should be
hospitalized. However, there is a subset of patients presenting with dyspnea and edema due to
volume overload that necessitate rapid symptom improvement but are hemodynamically stable.
Oral diuretics would likely be ineffective but hospital admission for IV diuretics seems
excessive.
The research hypothesis is that subcutaneously administered furosemide will be an effective
alternative to IV furosemide for hemodynamically stable chronic heart failure patients
presenting with volume overload in the ambulatory setting. Patients will be randomized to
receive Furosemide Injection, USP intravenously or Furosemide Injection Solution (SCP-101)
delivered subcutaneously. The IV patients will get the usual care of the heart failure
clinic, which includes having an IV placed and delivery of a one-time dose of IV furosemide
with the dose determined by the providers (maximum dose 160mg IV). The subcutaneous patients
will receive 80mg of Furosemide Injection Solution (SCP-101) administered subcutaneously over
5 hours (30mg in first hour and 12.5mg/hour for 4 hours).
Both groups of patients will be observed for 6 hours to assess diuresis. Patients will be
asked to fill out a survey about their symptom improvement (Kansas City Cardiomyopathy
questionnaire) and overall satisfaction related to the treatment experience. They will also
be monitored for side effects including ototoxicity and discomfort at the access site
(burning, itching, and pain). Electrolytes and renal function will be checked once after the
patients receive diuretic therapy.
of chronic heart failure, in-hospital mortality and readmission are high. Heart failure costs
the US about 32 billion per year, and a large percentage of the costs are due to
hospitalizations. Most clinicians would agree that patients with decompensated heart failure
presenting with hypotension, worsening renal function and altered mental status should be
hospitalized. However, there is a subset of patients presenting with dyspnea and edema due to
volume overload that necessitate rapid symptom improvement but are hemodynamically stable.
Oral diuretics would likely be ineffective but hospital admission for IV diuretics seems
excessive.
The research hypothesis is that subcutaneously administered furosemide will be an effective
alternative to IV furosemide for hemodynamically stable chronic heart failure patients
presenting with volume overload in the ambulatory setting. Patients will be randomized to
receive Furosemide Injection, USP intravenously or Furosemide Injection Solution (SCP-101)
delivered subcutaneously. The IV patients will get the usual care of the heart failure
clinic, which includes having an IV placed and delivery of a one-time dose of IV furosemide
with the dose determined by the providers (maximum dose 160mg IV). The subcutaneous patients
will receive 80mg of Furosemide Injection Solution (SCP-101) administered subcutaneously over
5 hours (30mg in first hour and 12.5mg/hour for 4 hours).
Both groups of patients will be observed for 6 hours to assess diuresis. Patients will be
asked to fill out a survey about their symptom improvement (Kansas City Cardiomyopathy
questionnaire) and overall satisfaction related to the treatment experience. They will also
be monitored for side effects including ototoxicity and discomfort at the access site
(burning, itching, and pain). Electrolytes and renal function will be checked once after the
patients receive diuretic therapy.
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
We found this trial at
1
site
Baltimore, Maryland 21287
Principal Investigator: Stuart Russell, MD
Phone: 202-441-1026
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