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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
Sponsor:
Collaborator:
scPharmaceuticals, Inc.
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Congestive Heart Failure
Interventions Drug: Furosemide Injection Solution (SCP-101)
Drug: Furosemide Injection Solution, USP
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Furosemide IV Furosemide Subcutaneous (SC)
Hide Arm/Group Description

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)

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)

Period Title: Overall Study
Started 19 21
Completed 19 21
Not Completed 0 0
Arm/Group Title Furosemide IV Furosemide Subcutaneous (SC) Total
Hide Arm/Group Description

Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment)

Furosemide Injection Solution, USP

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 of all reporting groups
Overall Number of Baseline Participants 19 21 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 21 participants 40 participants
54  (13) 59  (13) 57  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 21 participants 40 participants
Female
9
  47.4%
13
  61.9%
22
  55.0%
Male
10
  52.6%
8
  38.1%
18
  45.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 21 participants 40 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   4.8%
1
   2.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
14
  73.7%
12
  57.1%
26
  65.0%
White
5
  26.3%
8
  38.1%
13
  32.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 19 participants 21 participants 40 participants
19
 100.0%
21
 100.0%
40
 100.0%
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 19 participants 21 participants 40 participants
39.7  (11.2) 37.8  (11.3) 38.7  (11.2)
Ejection fraction  
Median (Inter-Quartile Range)
Unit of measure:  % left ventricular function
Number Analyzed 19 participants 21 participants 40 participants
20
(20 to 55)
25
(15 to 55)
25
(15 to 55)
Furosemide daily dose  
Mean (Standard Deviation)
Unit of measure:  Mg
Number Analyzed 19 participants 21 participants 40 participants
228  (174) 261  (164) 246  (167)
1.Primary Outcome
Title Urine Output
Hide Description The volume of urine produced in milliliters over the 6 hours after drug delivery will be measured.
Time Frame 6-hour period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Furosemide IV Furosemide SC
Hide Arm/Group Description:

Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment)

Furosemide Injection Solution, USP

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 Number of Participants Analyzed 19 21
Mean (Standard Deviation)
Unit of Measure: mL
1636  (875) 1515  (1000)
2.Secondary Outcome
Title Heart Failure Symptom Scoring/Symptom Improvement
Hide Description Will evaluate if subjective heart failure symptoms improve over the period of diuresis. Measured by Kansas City Cardiomyopathy Questionnaire
Time Frame 6-hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected on enough patients to accurately analyze this endpoint. No data analysis was performed for this outcome.
Arm/Group Title Furosemide IV Furosemide SC
Hide Arm/Group Description:

Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment)

Furosemide Injection Solution, USP

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Number of Participants With Side Effects
Hide Description Cumulative total of pain, local skin reactions (including hematoma and induration) and electrolyte abnormalities.
Time Frame Up to 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Furosemide IV Furosemide SC
Hide Arm/Group Description:

Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment)

Furosemide Injection Solution, USP

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 Number of Participants Analyzed 19 21
Measure Type: Count of Participants
Unit of Measure: Participants
Hypokalemia
0
   0.0%
1
   4.8%
Skin irritation
0
   0.0%
0
   0.0%
Infusion site pain
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Urine Sodium
Hide Description Total urinary sodium produced during the 6 hour urine collection
Time Frame 6-hour period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Furosemide IV Furosemide SC
Hide Arm/Group Description:

Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment)

Furosemide Injection Solution, USP

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 Number of Participants Analyzed 19 21
Mean (Standard Deviation)
Unit of Measure: mEq/L
7.3  (35.3) 32.8  (43.6)
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Furosemide IV Furosemide Subcutaneous (SC)
Hide Arm/Group Description

Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment)

Furosemide Injection Solution, USP

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)

All-Cause Mortality
Furosemide IV Furosemide Subcutaneous (SC)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)      0/21 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Furosemide IV Furosemide Subcutaneous (SC)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      0/21 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Furosemide IV Furosemide Subcutaneous (SC)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      1/21 (4.76%)    
General disorders     
Hypokalemia  [1]  0/19 (0.00%)  0 1/21 (4.76%)  1
Indicates events were collected by systematic assessment
[1]
Serum potassium < 3.5 mEq/L
This was a phase II exploratory trial with a small sample size
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Stuart Russell MD
Organization: Johns Hopkins Hospital
Phone: 4109555708
EMail: srusse14@jhmi.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02579057     History of Changes
Other Study ID Numbers: IRB00068019
First Submitted: October 14, 2015
First Posted: October 19, 2015
Results First Submitted: September 20, 2017
Results First Posted: November 17, 2017
Last Update Posted: December 18, 2017