Trial Outcomes & Findings for Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failure - A Pilot Study (NCT NCT04593823)
NCT ID: NCT04593823
Last Updated: 2023-08-01
Results Overview
Win Ratio calculated as number of pairs of Furoscix On-Body Infusor subject "wins" divided by number of pairs of Furoscix On-Body Infusor subject "losses" when compared to Continued Medical Therapy subjects. Components of Endpoint composite outcome: CV death, HF hospitalization, Urgent ED/Clinic visit at 30 days and percent change in NT-proBNP from baseline at Day 7. See Statistical Analysis Plan for detailed explanation of this statistical method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
Day 7, Day 30
Results posted on
2023-08-01
Participant Flow
12 Screen Failures
Participant milestones
| Measure |
Furoscix Infusor
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours).
Furoscix Infusor: Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours.
|
Continued Medical Therapy
The subjects enrolled in this arm will receive Continued Medical Treatment as usual as per the investigator
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
17
|
|
Overall Study
COMPLETED
|
33
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Furoscix Infusor
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours).
Furoscix Infusor: Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours.
|
Continued Medical Therapy
The subjects enrolled in this arm will receive Continued Medical Treatment as usual as per the investigator
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
2 subjects missing NT pro-BNP from both groups
Baseline characteristics by cohort
| Measure |
Total
n=51 Participants
Total of all reporting groups
|
Furoscix Infusor
n=34 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours).
Furoscix Infusor: Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours.
|
Continued Medical Therapy
n=17 Participants
The subjects enrolled in this arm will receive Continued Medical Treatment as usual as per the investigator
|
|---|---|---|---|
|
Age, Continuous
|
66.0 Years
STANDARD_DEVIATION 11.43 • n=51 Participants
|
63.5 Years
STANDARD_DEVIATION 10.91 • n=34 Participants
|
71.1 Years
STANDARD_DEVIATION 11.03 • n=17 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=51 Participants
|
9 Participants
n=34 Participants
|
6 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=51 Participants
|
25 Participants
n=34 Participants
|
11 Participants
n=17 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=51 Participants
|
3 Participants
n=34 Participants
|
0 Participants
n=17 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=51 Participants
|
31 Participants
n=34 Participants
|
17 Participants
n=17 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=17 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=17 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=51 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=17 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=17 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=51 Participants
|
11 Participants
n=34 Participants
|
4 Participants
n=17 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=51 Participants
|
23 Participants
n=34 Participants
|
13 Participants
n=17 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=17 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=17 Participants
|
|
Body Weight
|
112.28 Kilograms (Kg)
STANDARD_DEVIATION 32.99 • n=51 Participants
|
112.56 Kilograms (Kg)
STANDARD_DEVIATION 34.52 • n=34 Participants
|
111.70 Kilograms (Kg)
STANDARD_DEVIATION 30.7 • n=17 Participants
|
|
Body Mass Index
|
36.21 kg/m^2
STANDARD_DEVIATION 8.52 • n=51 Participants
|
36.02 kg/m^2
STANDARD_DEVIATION 7.88 • n=34 Participants
|
36.59 kg/m^2
STANDARD_DEVIATION 9.92 • n=17 Participants
|
|
New York Heart Association Class
Class I
|
0 Participants
n=51 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=17 Participants
|
|
New York Heart Association Class
Class II
|
6 Participants
n=51 Participants
|
2 Participants
n=34 Participants
|
4 Participants
n=17 Participants
|
|
New York Heart Association Class
Class III
|
43 Participants
n=51 Participants
|
31 Participants
n=34 Participants
|
12 Participants
n=17 Participants
|
|
New York Heart Association Class
Class IV
|
2 Participants
n=51 Participants
|
1 Participants
n=34 Participants
|
1 Participants
n=17 Participants
|
|
NT-proBNP
|
3276.4 pg/mL
STANDARD_DEVIATION 4096.51 • n=47 Participants • 2 subjects missing NT pro-BNP from both groups
|
2249.4 pg/mL
STANDARD_DEVIATION 3208.04 • n=32 Participants • 2 subjects missing NT pro-BNP from both groups
|
5467.5 pg/mL
STANDARD_DEVIATION 4979.57 • n=15 Participants • 2 subjects missing NT pro-BNP from both groups
|
|
Daily Furosemide Equivalent Dose
|
139.2 mg
STANDARD_DEVIATION 132.42 • n=50 Participants • One subject was not receiving any oral loop diuretics at baseline
|
146.7 mg
STANDARD_DEVIATION 141.66 • n=33 Participants • One subject was not receiving any oral loop diuretics at baseline
|
124.7 mg
STANDARD_DEVIATION 115.01 • n=17 Participants • One subject was not receiving any oral loop diuretics at baseline
|
PRIMARY outcome
Timeframe: Day 7, Day 30Population: All randomized subjects
Win Ratio calculated as number of pairs of Furoscix On-Body Infusor subject "wins" divided by number of pairs of Furoscix On-Body Infusor subject "losses" when compared to Continued Medical Therapy subjects. Components of Endpoint composite outcome: CV death, HF hospitalization, Urgent ED/Clinic visit at 30 days and percent change in NT-proBNP from baseline at Day 7. See Statistical Analysis Plan for detailed explanation of this statistical method.
Outcome measures
| Measure |
Furoscix Infusor
n=34 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours).
Furoscix Infusor: Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours.
|
Continued Medical Therapy
n=17 Participants
The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator
|
|---|---|---|
|
Win Ratio of Composite Endpoint
|
228 Number of Wins for the group
|
206 Number of Wins for the group
|
PRIMARY outcome
Timeframe: Baseline, 30 DaysPopulation: All randomized subjects
Total number of CV deaths between two groups
Outcome measures
| Measure |
Furoscix Infusor
n=34 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours).
Furoscix Infusor: Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours.
|
Continued Medical Therapy
n=17 Participants
The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator
|
|---|---|---|
|
Number of Cardiovascular Deaths
No
|
33 Participants
|
17 Participants
|
|
Number of Cardiovascular Deaths
Yes
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 30 DaysPopulation: All randomized subjects
Heart Failure hospitalizations compared between two groups
Outcome measures
| Measure |
Furoscix Infusor
n=34 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours).
Furoscix Infusor: Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours.
|
Continued Medical Therapy
n=17 Participants
The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator
|
|---|---|---|
|
Number of Heart Failure Hospitalizations
No
|
29 Participants
|
13 Participants
|
|
Number of Heart Failure Hospitalizations
Yes
|
5 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 30 DaysPopulation: All randomized subjects
Urgent ED/Clinic visits for worsening heart failure compared between two groups. Statistical analysis was not performed due to no ED/Clinic visits
Outcome measures
| Measure |
Furoscix Infusor
n=34 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours).
Furoscix Infusor: Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours.
|
Continued Medical Therapy
n=17 Participants
The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator
|
|---|---|---|
|
Number of Urgent ED/Clinic Visits for Worsening Heart Failure
No
|
34 Participants
|
17 Participants
|
|
Number of Urgent ED/Clinic Visits for Worsening Heart Failure
Yes
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 30 DaysPopulation: All randomized subjects
Percentage change in NT-proBNP from baseline at Day 7 compared between two groups
Outcome measures
| Measure |
Furoscix Infusor
n=30 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours).
Furoscix Infusor: Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours.
|
Continued Medical Therapy
n=11 Participants
The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator
|
|---|---|---|
|
NT-proBNP Change From Baseline
|
-7.195 percentage change from baseline (pg/mL)
Interval -55.27 to 379.58
|
-2.170 percentage change from baseline (pg/mL)
Interval -53.37 to 36.08
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: All randomized subjects
Out of 30 days, HF event-free survival is the average number of days subjects survived outside the hospital event-free.
Outcome measures
| Measure |
Furoscix Infusor
n=34 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours).
Furoscix Infusor: Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours.
|
Continued Medical Therapy
n=17 Participants
The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator
|
|---|---|---|
|
Number of Heart Failure Event Free Survival Days
|
23.2 days
Standard Deviation 4.79
|
14.3 days
Standard Deviation 10.14
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: All randomized subjects
Subjects that are Deceased or HF event occurred (hospitalization for HF or urgent ED/clinic visits for HF) over 30 days compared between treatment groups.
Outcome measures
| Measure |
Furoscix Infusor
n=34 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours).
Furoscix Infusor: Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours.
|
Continued Medical Therapy
n=17 Participants
The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator
|
|---|---|---|
|
Number of Subjects Deceased or HF Event Occurred
No
|
28 Participants
|
13 Participants
|
|
Number of Subjects Deceased or HF Event Occurred
Yes
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, 7 Days, 30 DaysPopulation: All randomized subjects
The patient global assessment VAS is a patient-reported assessment of how good or bad a patient feels their health is on a given day. It is reported on a visual scale of 0 to 100, with 0 being the worst health they can imagine and 100 being the best health they can imagine.
Outcome measures
| Measure |
Furoscix Infusor
n=34 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours).
Furoscix Infusor: Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours.
|
Continued Medical Therapy
n=17 Participants
The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator
|
|---|---|---|
|
Visual Analog Scale (VAS)
Day 0
|
57.1 score on a scale
Standard Deviation 18.12
|
48.8 score on a scale
Standard Deviation 22.12
|
|
Visual Analog Scale (VAS)
Day 7
|
66.8 score on a scale
Standard Deviation 16.88
|
59.7 score on a scale
Standard Deviation 23.27
|
|
Visual Analog Scale (VAS)
Day 30
|
70.2 score on a scale
Standard Deviation 18.47
|
60.7 score on a scale
Standard Deviation 24.01
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 30Population: All randomized subjects
The composite congestion score (ccs) is calculated by summing the individual scores for orthopnea, pedal edema and jugular venous distension. The investigator-assessed the signs and symptoms of congestion (orthopnea, pedal edema, and jugular venous distension) on a 4-point grading scale ranging from 0 to 3. Higher score indicates greater severity of symptoms ranging from 0 to 9.
Outcome measures
| Measure |
Furoscix Infusor
n=34 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours).
Furoscix Infusor: Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours.
|
Continued Medical Therapy
n=17 Participants
The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator
|
|---|---|---|
|
Composite Congestion Score (CCS)
Day 0
|
3.9 score on a scale
Standard Deviation 1.58
|
3.7 score on a scale
Standard Deviation 1.72
|
|
Composite Congestion Score (CCS)
Day 7
|
2.2 score on a scale
Standard Deviation 2.18
|
2.6 score on a scale
Standard Deviation 1.79
|
|
Composite Congestion Score (CCS)
Day 30
|
1.5 score on a scale
Standard Deviation 1.75
|
2.1 score on a scale
Standard Deviation 2.52
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 30Population: All randomized subjects
The 5-Point Current Dyspnea Status Questionnaire is a single-item, self-administered instrument that quantifies current symptoms of dyspnea. The scale includes the absence of dyspnea (a score of 1), mild shortness of breath (a score of 2), moderate shortness of breath (a score of 3), severe shortness of breath (a score of 4) and the worst possible shortness of breath (a score of 5)
Outcome measures
| Measure |
Furoscix Infusor
n=34 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours).
Furoscix Infusor: Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours.
|
Continued Medical Therapy
n=17 Participants
The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator
|
|---|---|---|
|
5-Point Current Dyspnea Score
Day 0
|
1.3 score on a scale
Standard Deviation 1.0
|
1.8 score on a scale
Standard Deviation 1.15
|
|
5-Point Current Dyspnea Score
Day 7
|
0.8 score on a scale
Standard Deviation 0.90
|
1.1 score on a scale
Standard Deviation 0.93
|
|
5-Point Current Dyspnea Score
Day 30
|
0.9 score on a scale
Standard Deviation 0.82
|
1.3 score on a scale
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Day 7, Day 30Population: All randomized subjects
The 7-Point Dyspnea Status Questionnaire is a single-item, self-administered instrument that quantifies changes in dyspnea symptoms since initiation of study product. The scale ranges from Markedly better, Moderately better, Minimaly better, No change, Minimally worse, Moderately worse to Markedly worse.
Outcome measures
| Measure |
Furoscix Infusor
n=34 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours).
Furoscix Infusor: Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours.
|
Continued Medical Therapy
n=17 Participants
The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator
|
|---|---|---|
|
7-Point Dyspnea Score
Day 3 · Markedly Better
|
3 Participants
|
1 Participants
|
|
7-Point Dyspnea Score
Day 3 · Moderately Better
|
12 Participants
|
0 Participants
|
|
7-Point Dyspnea Score
Day 3 · Minimally Better
|
8 Participants
|
4 Participants
|
|
7-Point Dyspnea Score
Day 3 · No Change
|
8 Participants
|
8 Participants
|
|
7-Point Dyspnea Score
Day 3 · Minimally Worse
|
1 Participants
|
0 Participants
|
|
7-Point Dyspnea Score
Day 3 · Moderately Worse
|
0 Participants
|
1 Participants
|
|
7-Point Dyspnea Score
Day 3 · Markedly Worse
|
0 Participants
|
1 Participants
|
|
7-Point Dyspnea Score
Day 3 · Missing
|
2 Participants
|
2 Participants
|
|
7-Point Dyspnea Score
Day 7 · Markedly Better
|
4 Participants
|
2 Participants
|
|
7-Point Dyspnea Score
Day 7 · Moderately Better
|
13 Participants
|
3 Participants
|
|
7-Point Dyspnea Score
Day 7 · Minimally Better
|
5 Participants
|
4 Participants
|
|
7-Point Dyspnea Score
Day 7 · No Change
|
12 Participants
|
6 Participants
|
|
7-Point Dyspnea Score
Day 7 · Minimally Worse
|
0 Participants
|
0 Participants
|
|
7-Point Dyspnea Score
Day 7 · Moderately Worse
|
0 Participants
|
0 Participants
|
|
7-Point Dyspnea Score
Day 7 · Markedly Worse
|
0 Participants
|
0 Participants
|
|
7-Point Dyspnea Score
Day 7 · Missing
|
0 Participants
|
2 Participants
|
|
7-Point Dyspnea Score
Day 30 · Markedly Better
|
6 Participants
|
0 Participants
|
|
7-Point Dyspnea Score
Day 30 · Moderately Better
|
13 Participants
|
5 Participants
|
|
7-Point Dyspnea Score
Day 30 · Minimally Better
|
6 Participants
|
3 Participants
|
|
7-Point Dyspnea Score
Day 30 · No Change
|
5 Participants
|
6 Participants
|
|
7-Point Dyspnea Score
Day 30 · Minimally Worse
|
2 Participants
|
0 Participants
|
|
7-Point Dyspnea Score
Day 30 · Moderately Worse
|
1 Participants
|
0 Participants
|
|
7-Point Dyspnea Score
Day 30 · Markedly Worse
|
0 Participants
|
0 Participants
|
|
7-Point Dyspnea Score
Day 30 · Missing
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, 7 Days, 30 DaysPopulation: All randomized subjects
The KCCQ-12 questionnaire is a patient-reported assessment to capture symptom frequency, physical and social limitations, and quality-of-life impairment as a result of HF, as well as an overall summary score. In the KCCQ-12, responses are given for each individual item is scored on a scale of 0-100 with higher scores indicating better health.
Outcome measures
| Measure |
Furoscix Infusor
n=34 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours).
Furoscix Infusor: Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours.
|
Continued Medical Therapy
n=17 Participants
The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator
|
|---|---|---|
|
KCCQ-12 Summary Score
Baseline
|
40.96 units on a scale
Standard Deviation 18.296
|
30.54 units on a scale
Standard Deviation 25.395
|
|
KCCQ-12 Summary Score
Day 7
|
51.55 units on a scale
Standard Deviation 20.388
|
36.68 units on a scale
Standard Deviation 24.074
|
|
KCCQ-12 Summary Score
Day 30
|
55.80 units on a scale
Standard Deviation 24.480
|
45.33 units on a scale
Standard Deviation 28.624
|
SECONDARY outcome
Timeframe: Baseline, 7 Days, 30 DaysPopulation: All randomized subjects
Change from baseline in Six-Minute Walk Test (6MWT) across follow-up timepoints
Outcome measures
| Measure |
Furoscix Infusor
n=34 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours).
Furoscix Infusor: Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours.
|
Continued Medical Therapy
n=17 Participants
The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator
|
|---|---|---|
|
Six-Minute Walk Test (6MWT)
Baseline
|
241.7 meters
Standard Deviation 115.89
|
177.6 meters
Standard Deviation 77.65
|
|
Six-Minute Walk Test (6MWT)
Day 7
|
269.0 meters
Standard Deviation 126.63
|
201.0 meters
Standard Deviation 85.32
|
|
Six-Minute Walk Test (6MWT)
Day 30
|
292.3 meters
Standard Deviation 112.76
|
192.3 meters
Standard Deviation 71.17
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 30Population: All randomized subjects
Lung fluid volume as measured via Remote Dielectric Sensing (ReDS)
Outcome measures
| Measure |
Furoscix Infusor
n=34 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours).
Furoscix Infusor: Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours.
|
Continued Medical Therapy
n=17 Participants
The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator
|
|---|---|---|
|
Percent Lung Fluid
Day 0
|
36.8 % Fluid Volume in Lungs
Standard Deviation 6.41
|
34.5 % Fluid Volume in Lungs
Standard Deviation 6.70
|
|
Percent Lung Fluid
Day 7
|
34.8 % Fluid Volume in Lungs
Standard Deviation 6.09
|
31.3 % Fluid Volume in Lungs
Standard Deviation 6.25
|
|
Percent Lung Fluid
Day 30
|
35.6 % Fluid Volume in Lungs
Standard Deviation 6.60
|
34.4 % Fluid Volume in Lungs
Standard Deviation 6.35
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Day 7, Day 30Population: All randomized subjects
Body weight of the patient on the day of visit
Outcome measures
| Measure |
Furoscix Infusor
n=34 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours).
Furoscix Infusor: Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours.
|
Continued Medical Therapy
n=17 Participants
The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator
|
|---|---|---|
|
Body Weight
Day 0
|
112.563 Kilograms
Standard Deviation 34.516
|
111.704 Kilograms
Standard Deviation 30.697
|
|
Body Weight
Day 3
|
110.748 Kilograms
Standard Deviation 34.590
|
115.524 Kilograms
Standard Deviation 30.942
|
|
Body Weight
Day 7
|
109.935 Kilograms
Standard Deviation 33.996
|
116.199 Kilograms
Standard Deviation 28.781
|
|
Body Weight
Day 30
|
110.357 Kilograms
Standard Deviation 35.201
|
117.422 Kilograms
Standard Deviation 30.879
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Day 7, Day 30Population: All randomized subjects
Change from baseline in serum creatinine
Outcome measures
| Measure |
Furoscix Infusor
n=34 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours).
Furoscix Infusor: Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours.
|
Continued Medical Therapy
n=17 Participants
The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator
|
|---|---|---|
|
Renal Function
Day 0
|
1.496 mg/dL
Standard Deviation 0.608
|
1.696 mg/dL
Standard Deviation 0.747
|
|
Renal Function
Day 3
|
1.611 mg/dL
Standard Deviation 0.541
|
1.894 mg/dL
Standard Deviation 0.861
|
|
Renal Function
Day 7
|
1.648 mg/dL
Standard Deviation 0.747
|
1.811 mg/dL
Standard Deviation 0.860
|
|
Renal Function
Day 30
|
1.641 mg/dL
Standard Deviation 0.771
|
2.010 mg/dL
Standard Deviation 1.147
|
Adverse Events
Furoscix Infusor
Serious events: 12 serious events
Other events: 23 other events
Deaths: 2 deaths
Continued Medical Therapy
Serious events: 4 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Furoscix Infusor
n=34 participants at risk
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours).
Furoscix Infusor: Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours.
|
Continued Medical Therapy
n=17 participants at risk
The subjects enrolled in this arm received treatment as usual as per the investigator.
|
|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
20.6%
7/34 • 30 Days
|
23.5%
4/17 • 30 Days
|
|
Cardiac disorders
Left ventricular hypertrophy
|
2.9%
1/34 • 30 Days
|
0.00%
0/17 • 30 Days
|
|
Cardiac disorders
Ventricular tachycardia
|
2.9%
1/34 • 30 Days
|
0.00%
0/17 • 30 Days
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/34 • 30 Days
|
5.9%
1/17 • 30 Days
|
|
Infections and infestations
Pneumonia
|
2.9%
1/34 • 30 Days
|
0.00%
0/17 • 30 Days
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/34 • 30 Days
|
0.00%
0/17 • 30 Days
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
1/34 • 30 Days
|
0.00%
0/17 • 30 Days
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
2.9%
1/34 • 30 Days
|
0.00%
0/17 • 30 Days
|
|
Vascular disorders
Hypertensive crisis
|
2.9%
1/34 • 30 Days
|
0.00%
0/17 • 30 Days
|
|
Vascular disorders
Shock haemorrhagic
|
2.9%
1/34 • 30 Days
|
0.00%
0/17 • 30 Days
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
1/34 • 30 Days
|
0.00%
0/17 • 30 Days
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/34 • 30 Days
|
5.9%
1/17 • 30 Days
|
|
General disorders
Sudden cardiac death
|
2.9%
1/34 • 30 Days
|
0.00%
0/17 • 30 Days
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
2.9%
1/34 • 30 Days
|
0.00%
0/17 • 30 Days
|
|
Nervous system disorders
Syncope
|
2.9%
1/34 • 30 Days
|
0.00%
0/17 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
2.9%
1/34 • 30 Days
|
0.00%
0/17 • 30 Days
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/34 • 30 Days
|
5.9%
1/17 • 30 Days
|
Other adverse events
| Measure |
Furoscix Infusor
n=34 participants at risk
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours).
Furoscix Infusor: Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours.
|
Continued Medical Therapy
n=17 participants at risk
The subjects enrolled in this arm received treatment as usual as per the investigator.
|
|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
11.8%
4/34 • 30 Days
|
0.00%
0/17 • 30 Days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.6%
7/34 • 30 Days
|
0.00%
0/17 • 30 Days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.9%
1/34 • 30 Days
|
5.9%
1/17 • 30 Days
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/34 • 30 Days
|
5.9%
1/17 • 30 Days
|
|
General disorders
Infusion site pain
|
14.7%
5/34 • 30 Days
|
0.00%
0/17 • 30 Days
|
|
General disorders
Infusion site bruising
|
5.9%
2/34 • 30 Days
|
0.00%
0/17 • 30 Days
|
|
General disorders
Asthenia
|
0.00%
0/34 • 30 Days
|
5.9%
1/17 • 30 Days
|
|
Renal and urinary disorders
Renal impairment
|
14.7%
5/34 • 30 Days
|
11.8%
2/17 • 30 Days
|
|
Gastrointestinal disorders
Nausea
|
8.8%
3/34 • 30 Days
|
0.00%
0/17 • 30 Days
|
|
Investigations
Blood creatinine increased
|
5.9%
2/34 • 30 Days
|
0.00%
0/17 • 30 Days
|
|
Infections and infestations
Pneumonia
|
2.9%
1/34 • 30 Days
|
5.9%
1/17 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
2/34 • 30 Days
|
5.9%
1/17 • 30 Days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/34 • 30 Days
|
5.9%
1/17 • 30 Days
|
|
General disorders
Fatigue
|
2.9%
1/34 • 30 Days
|
11.8%
2/17 • 30 Days
|
|
Investigations
Weight increase
|
0.00%
0/34 • 30 Days
|
5.9%
1/17 • 30 Days
|
Additional Information
Dr. John Mohr, PharmD; Sr VP Clinical Development and Medical Affairs
scPharmaceuticals
Phone: 7813017220
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place