Trial Outcomes & Findings for Sub-Q Versus IV Furosemide in Acute Heart Failure (NCT NCT02579057)

NCT ID: NCT02579057

Last Updated: 2017-12-18

Results Overview

The volume of urine produced in milliliters over the 6 hours after drug delivery will be measured.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 40 participants
• Primary outcome timeframe: 6-hour period
• Results posted on: 2017-12-18

Participant Flow

Participant milestones

Measure	Furosemide IV Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment) Furosemide Injection Solution, United States Pharmacopeia (USP)	Furosemide Subcutaneous (SC) 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) Furosemide Injection Solution (SCP-101)
Overall Study STARTED	19	21
Overall Study COMPLETED	19	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sub-Q Versus IV Furosemide in Acute Heart Failure

Baseline characteristics by cohort

Measure	Furosemide IV n=19 Participants Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment) Furosemide Injection Solution, USP	Furosemide Subcutaneous (SC) n=21 Participants 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) Furosemide Injection Solution (SCP-101)	Total n=40 Participants Total of all reporting groups
Age, Continuous	54 years STANDARD_DEVIATION 13 • n=5 Participants	59 years STANDARD_DEVIATION 13 • n=7 Participants	57 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Body mass index	39.7 kg/m2 STANDARD_DEVIATION 11.2 • n=5 Participants	37.8 kg/m2 STANDARD_DEVIATION 11.3 • n=7 Participants	38.7 kg/m2 STANDARD_DEVIATION 11.2 • n=5 Participants
Ejection fraction	20 % left ventricular function n=5 Participants	25 % left ventricular function n=7 Participants	25 % left ventricular function n=5 Participants
Furosemide daily dose	228 mg STANDARD_DEVIATION 174 • n=5 Participants	261 mg STANDARD_DEVIATION 164 • n=7 Participants	246 mg STANDARD_DEVIATION 167 • n=5 Participants

PRIMARY outcome

Timeframe: 6-hour period

The volume of urine produced in milliliters over the 6 hours after drug delivery will be measured.

Outcome measures

Measure	Furosemide IV n=19 Participants Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment) Furosemide Injection Solution, USP	Furosemide SC n=21 Participants 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) Furosemide Injection Solution (SCP-101)
Urine Output	1636 mL Standard Deviation 875	1515 mL Standard Deviation 1000

SECONDARY outcome

Timeframe: 6-hour period

Population: Data was not collected on enough patients to accurately analyze this endpoint. No data analysis was performed for this outcome.

Will evaluate if subjective heart failure symptoms improve over the period of diuresis. Measured by Kansas City Cardiomyopathy Questionnaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 hours

Cumulative total of pain, local skin reactions (including hematoma and induration) and electrolyte abnormalities.

Outcome measures

Measure	Furosemide IV n=19 Participants Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment) Furosemide Injection Solution, USP	Furosemide SC n=21 Participants 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) Furosemide Injection Solution (SCP-101)
Number of Participants With Side Effects Hypokalemia	0 Participants	1 Participants
Number of Participants With Side Effects Skin irritation	0 Participants	0 Participants
Number of Participants With Side Effects Infusion site pain	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6-hour period

Total urinary sodium produced during the 6 hour urine collection

Outcome measures

Measure	Furosemide IV n=19 Participants Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment) Furosemide Injection Solution, USP	Furosemide SC n=21 Participants 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) Furosemide Injection Solution (SCP-101)
Urine Sodium	7.3 mEq/L Standard Deviation 35.3	32.8 mEq/L Standard Deviation 43.6

Adverse Events

Furosemide IV

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Furosemide Subcutaneous (SC)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Furosemide IV n=19 participants at risk Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment) Furosemide Injection Solution, USP	Furosemide Subcutaneous (SC) n=21 participants at risk 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) Furosemide Injection Solution (SCP-101)
General disorders Hypokalemia	0.00% 0/19 • 1 month	4.8% 1/21 • Number of events 1 • 1 month

Additional Information

Stuart Russell MD

Johns Hopkins Hospital

Phone: 4109555708

Email: srusse14@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place