Sub-Q Versus IV Furosemide in Acute Heart Failure
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|ClinicalTrials.gov Identifier: NCT02579057|
Recruitment Status : Completed
First Posted : October 19, 2015
Results First Posted : November 17, 2017
Last Update Posted : December 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Congestive Heart Failure||Drug: Furosemide Injection Solution (SCP-101) Drug: Furosemide Injection Solution, USP||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Randomized, Parallel-Group Pilot Study Comparing IV Furosemide to Subcutaneous Furosemide in Acute Decompensated Heart Failure Patients|
|Actual Study Start Date :||February 2016|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||July 2017|
Active Comparator: Furosemide Injection Solution, USP
Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment)
Drug: Furosemide Injection Solution, USP
Other Name: IV furosemide
Experimental: Furosemide Injection Solution (SCP-101)
80 mg dose administered subcutaneously as 30 mg over the first hour and then as 12.5 mg per hour over the subsequent 4 hours (test treatment)
Drug: Furosemide Injection Solution (SCP-101)
Other Name: sc Furosemide
- Urine Output [ Time Frame: 6-hour period ]The volume of urine produced in milliliters over the 6 hours after drug delivery will be measured.
- Heart Failure Symptom Scoring/Symptom Improvement [ Time Frame: 6-hour period ]Will evaluate if subjective heart failure symptoms improve over the period of diuresis. Measured by Kansas City Cardiomyopathy Questionnaire
- Number of Participants With Side Effects [ Time Frame: Up to 6 hours ]Cumulative total of pain, local skin reactions (including hematoma and induration) and electrolyte abnormalities.
- Urine Sodium [ Time Frame: 6-hour period ]Total urinary sodium produced during the 6 hour urine collection
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579057
|United States, Maryland|
|Johns Hopkins Hospital Heart Failure Bridge Clinic|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Stuart Russell, MD||Johns Hopkins University|