Trial Outcomes & Findings for Furoscix Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure (NCT NCT03458325)
NCT ID: NCT03458325
Last Updated: 2023-02-24
Results Overview
The difference in the overall and heart failure related healthcare costs between subjects treated with the Furoscix Infusor through 30 days post discharge from the emergency department compared to matched controls treated in the hospital for ≤ 72 hours through 30 days post discharge.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
27 participants
Primary outcome timeframe
Day 0 - Day 30
Results posted on
2023-02-24
Participant Flow
2 subjects excluded after signing consent: * 1 subject met exclusion criteria due to lab abnormality (creatinine clearance, serum creatinine) * 1 subject met exclusion criteria due to requiring hospitalization (hypoxia and hypertension)
Participant milestones
| Measure |
Furoscix Infusor Prospective Treatment
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor outside the hospital.
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.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Furoscix Infusor Prospective Treatment
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor outside the hospital.
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.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Furoscix Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure
Baseline characteristics by cohort
| Measure |
Furoscix Infusor Prospective Treatment
n=24 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor outside the hospital.
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.
|
|---|---|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 12.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Subject's Insurance at baseline
Medicare
|
8 Participants
n=5 Participants
|
|
Subject's Insurance at baseline
Medicaid
|
4 Participants
n=5 Participants
|
|
Subject's Insurance at baseline
Commercial
|
10 Participants
n=5 Participants
|
|
Subject's Insurance at baseline
Unknown
|
2 Participants
n=5 Participants
|
|
NYHA Classification
NYHA Class I
|
0 Participants
n=5 Participants
|
|
NYHA Classification
NYHA Class II
|
4 Participants
n=5 Participants
|
|
NYHA Classification
NYHA Class III
|
20 Participants
n=5 Participants
|
|
NYHA Classification
NYHA Class IV
|
0 Participants
n=5 Participants
|
|
Signs of volume expansion at baseline
Jugular Venous Distention
|
4 Participants
n=5 Participants
|
|
Signs of volume expansion at baseline
Pitting Edema
|
18 Participants
n=5 Participants
|
|
Signs of volume expansion at baseline
Abdominal Distention
|
9 Participants
n=5 Participants
|
|
Signs of volume expansion at baseline
Pulmonary Congestion on Chest X-ray
|
6 Participants
n=5 Participants
|
|
Signs of volume expansion at baseline
Pulmonary Rales
|
5 Participants
n=5 Participants
|
|
History of Congestive Heart Failure (CHF)
|
4.26 Years
STANDARD_DEVIATION 4.917 • n=5 Participants
|
|
Etiology of Congestive Heart Failure (CHF) at baseline
Ischemic
|
9 Participants
n=5 Participants
|
|
Etiology of Congestive Heart Failure (CHF) at baseline
Non-ischemic
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 - Day 30The difference in the overall and heart failure related healthcare costs between subjects treated with the Furoscix Infusor through 30 days post discharge from the emergency department compared to matched controls treated in the hospital for ≤ 72 hours through 30 days post discharge.
Outcome measures
| Measure |
Furoscix Infusor Prospective Treatment
n=24 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor outside the hospital.
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.
|
Matched Historical Control
The control arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF.
|
|---|---|---|
|
Healthcare Utilization Costs
HF-related healthcare costs
|
2920.30 US Dollars
Standard Deviation 7073.20
|
—
|
|
Healthcare Utilization Costs
Overall healthcare costs
|
7512.30 US Dollars
Standard Deviation 11,905.50
|
—
|
SECONDARY outcome
Timeframe: Day 0 - Day 30Population: Evaluable Population:
The HF-related admissions for the Furoscix patients compared to Control patients.
Outcome measures
| Measure |
Furoscix Infusor Prospective Treatment
n=24 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor outside the hospital.
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.
|
Matched Historical Control
The control arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF.
|
|---|---|---|
|
Heart-Failure Related Hospital Admissions
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 0 - Day 30Population: Evaluable Population
The differences in the percentage of subjects with an all-cause hospitalization in the Furoscix group and all-cause 30-day rehospitalization in the Control group in the 30 day follow-up period
Outcome measures
| Measure |
Furoscix Infusor Prospective Treatment
n=24 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor outside the hospital.
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.
|
Matched Historical Control
The control arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF.
|
|---|---|---|
|
All-Cause Hospital Admissions
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 0 - Day 30Population: Evaluable Population
The differences in the percentage of patients with HF-related emergency department visits in the Furoscix group and in the Control group in the 30 day follow-up period
Outcome measures
| Measure |
Furoscix Infusor Prospective Treatment
n=24 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor outside the hospital.
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.
|
Matched Historical Control
n=66 Participants
The control arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF.
|
|---|---|---|
|
Heart-Failure Related Emergency Department Visits
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 0 - Day 30The differences in the percentage of patients with HF-related clinic visits in the Furoscix group and in the Control group in the 30 day follow-up period
Outcome measures
| Measure |
Furoscix Infusor Prospective Treatment
n=24 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor outside the hospital.
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.
|
Matched Historical Control
The control arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF.
|
|---|---|---|
|
Heart-Failure Related Clinic Visits
|
24 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: Summary Score represents integration of Physical Limitation, Symptom Frequency, Quality of Life and Social Limitation Scores. Missing values were not included in this analysis
The Kansas City Cardiomyopathy Questionnaire (KCCQ) measures a patient's self-reported overall health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL). The KCCQ-12 overall summary score is the sum of responses from all 12 items ranging from 0 to 100 with higher scores to indicate better health status.
Outcome measures
| Measure |
Furoscix Infusor Prospective Treatment
n=24 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor outside the hospital.
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.
|
Matched Historical Control
n=24 Participants
The control arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF.
|
|---|---|---|
|
KCCQ-12 Scores
Summary Score
|
29.9 score on a scale
Standard Deviation 22.8
|
42.8 score on a scale
Standard Deviation 28.4
|
|
KCCQ-12 Scores
Physical Limitation Score
|
37.1 score on a scale
Standard Deviation 30.1
|
43.7 score on a scale
Standard Deviation 32.0
|
|
KCCQ-12 Scores
Symptom Frequency Score
|
33.1 score on a scale
Standard Deviation 28.6
|
50.5 score on a scale
Standard Deviation 32.3
|
|
KCCQ-12 Scores
Quality of Life Score
|
27.1 score on a scale
Standard Deviation 28.0
|
35.9 score on a scale
Standard Deviation 29.8
|
|
KCCQ-12 Scores
Social Limitation Score
|
29.0 score on a scale
Standard Deviation 26.1
|
40.9 score on a scale
Standard Deviation 31.3
|
SECONDARY outcome
Timeframe: Day 0 - Day 30Population: Evaluable Population. Subjects who are missing the NT-proBNP and BNP test results were excluded from this analysis.
Change in NT-proBNP and BNP change from baseline during the study period is summarized for the Furoscix group
Outcome measures
| Measure |
Furoscix Infusor Prospective Treatment
n=23 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor outside the hospital.
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.
|
Matched Historical Control
n=23 Participants
The control arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF.
|
|---|---|---|
|
Mean Change in NT-proBNP and BNP
NT-proBNP
|
823.4 pg/ml
Standard Deviation 1043.9
|
700.7 pg/ml
Standard Deviation 896.2
|
|
Mean Change in NT-proBNP and BNP
BNP
|
785.1 pg/ml
Standard Deviation 1129.9
|
263.5 pg/ml
Standard Deviation 384.0
|
SECONDARY outcome
Timeframe: Day 0 - Day 2-4 study visitPopulation: Evaluable Population
The Furoscix group was administered a Comfort of Wear Questionnaire during Day 2-4 study visit. This questionnaire measured the patient's general perception of comfortability wearing and using the device, the impact of wearing the device on their activities of daily living, and their satisfaction with the device.
Outcome measures
| Measure |
Furoscix Infusor Prospective Treatment
n=24 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor outside the hospital.
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.
|
Matched Historical Control
The control arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF.
|
|---|---|---|
|
Comfort of Wear Questionnaire
Please rate how comfortable or uncomfortable you felt wearing the device · Very Comfortable
|
6 Participants
|
—
|
|
Comfort of Wear Questionnaire
Please rate how comfortable or uncomfortable you felt wearing the device · Moderately Comfortable
|
9 Participants
|
—
|
|
Comfort of Wear Questionnaire
Please rate how comfortable or uncomfortable you felt wearing the device · Slightly Comfortable
|
3 Participants
|
—
|
|
Comfort of Wear Questionnaire
Please rate how comfortable or uncomfortable you felt wearing the device · Neither Comfortable or Uncomfortable
|
0 Participants
|
—
|
|
Comfort of Wear Questionnaire
Please rate how comfortable or uncomfortable you felt wearing the device · Slightly Uncomfortable
|
5 Participants
|
—
|
|
Comfort of Wear Questionnaire
Please rate how comfortable or uncomfortable you felt wearing the device · Moderately Uncomfortable
|
1 Participants
|
—
|
|
Comfort of Wear Questionnaire
Please rate how comfortable or uncomfortable you felt wearing the device · Very Uncomfortable
|
0 Participants
|
—
|
|
Comfort of Wear Questionnaire
Please rate how comfortable or uncomfortable you felt upon removal of the device · Very Comfortable
|
11 Participants
|
—
|
|
Comfort of Wear Questionnaire
Please rate how comfortable or uncomfortable you felt upon removal of the device · Moderately Comfortable
|
4 Participants
|
—
|
|
Comfort of Wear Questionnaire
Please rate how comfortable or uncomfortable you felt upon removal of the device · Slightly Comfortable
|
2 Participants
|
—
|
|
Comfort of Wear Questionnaire
Please rate how comfortable or uncomfortable you felt upon removal of the device · Neither Comfortable or Uncomfortable
|
4 Participants
|
—
|
|
Comfort of Wear Questionnaire
Please rate how comfortable or uncomfortable you felt upon removal of the device · Slightly Uncomfortable
|
1 Participants
|
—
|
|
Comfort of Wear Questionnaire
Please rate how comfortable or uncomfortable you felt upon removal of the device · Moderately Uncomfortable
|
1 Participants
|
—
|
|
Comfort of Wear Questionnaire
Please rate how comfortable or uncomfortable you felt upon removal of the device · Very Uncomfortable
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 0 - Day 2-4 study visitPopulation: Evaluable Population
The Furoscix group was administered a Comfort of Wear Questionnaire on Day 2-4. This questionnaire measured the patient's general perception of comfortability wearing and using the device, the impact of wearing the device on their activities of daily living, and their satisfaction with the device.
Outcome measures
| Measure |
Furoscix Infusor Prospective Treatment
n=24 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor outside the hospital.
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.
|
Matched Historical Control
The control arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF.
|
|---|---|---|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Sitting reading watching TV · 3 - Possibly
|
0 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Using the bathroom · 2 - Probably Not
|
2 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Using the bathroom · 3 - Possibly
|
1 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Walking · 1 - Not at all
|
19 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Walking · 2 - Probably Not
|
1 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Walking · 3 - Possibly
|
1 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Walking · 4 - Probably
|
1 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Walking · 5 - Completely
|
1 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Walking · Not Applicable
|
1 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Standing · 1 - Not at all
|
19 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Standing · 2 - Probably Not
|
1 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Standing · 3 - Possibly
|
1 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Standing · 4 - Probably
|
1 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Standing · 5 - Completely
|
1 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Standing · Not Applicable
|
1 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Sitting reading watching TV · 1 - Not at all
|
17 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Sitting reading watching TV · 2 - Probably Not
|
5 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Sitting reading watching TV · 4 - Probably
|
0 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Sitting reading watching TV · 5 - Completely
|
1 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Sitting reading watching TV · Not Applicable
|
1 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Lying down/napping · 1 - Not at all
|
13 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Lying down/napping · 2 - Probably Not
|
4 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Lying down/napping · 3 - Possibly
|
2 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Lying down/napping · 4 - Probably
|
2 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Lying down/napping · 5 - Completely
|
0 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Lying down/napping · Not Applicable
|
3 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Using the bathroom · 1 - Not at all
|
17 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Using the bathroom · 4 - Probably
|
3 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Using the bathroom · 5 - Completely
|
1 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Using the bathroom · Not Applicable
|
0 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Driving or riding in a car · 1 - Not at all
|
14 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Driving or riding in a car · 2 - Probably Not
|
4 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Driving or riding in a car · 3 - Possibly
|
1 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Driving or riding in a car · 4 - Probably
|
0 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Driving or riding in a car · 5 - Completely
|
0 Participants
|
—
|
|
Comfort of Wear Questionnaire: Interference With Activities Daily Living
If wearing the device interfered with activities of daily living - Driving or riding in a car · Not Applicable
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 0 - Day 2-4 study visitPopulation: Evaluable Population
The Furoscix group was administered a Comfort of Wear Questionnaire during Day 2-4 study visit. This questionnaire measured the patient's general perception of comfortability wearing and using the device, the impact of wearing the device on their activities of daily living, and their satisfaction with the device.
Outcome measures
| Measure |
Furoscix Infusor Prospective Treatment
n=24 Participants
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor outside the hospital.
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.
|
Matched Historical Control
The control arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF.
|
|---|---|---|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I think that I would like to use this product frequently · 1 - Strongly Disagree
|
0 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I think that I would like to use this product frequently · 2 - Disagree
|
2 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I think that I would like to use this product frequently · 3 - Neutral
|
7 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I think that I would like to use this product frequently · 4 - Agree
|
2 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I think that I would like to use this product frequently · 5 - Strongly Agree
|
13 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I found the product unnecessarily complex · 1 - Strongly Disagree
|
14 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I found the product unnecessarily complex · 2 - Disagree
|
7 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I found the product unnecessarily complex · 3 - Neutral
|
0 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I found the product unnecessarily complex · 4 - Agree
|
1 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I found the product unnecessarily complex · 5 - Strongly Agree
|
2 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I thought the product was easy to use · 1 - Strongly Disagree
|
0 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I thought the product was easy to use · 2 - Disagree
|
2 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I thought the product was easy to use · 3 - Neutral
|
0 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I thought the product was easy to use · 4 - Agree
|
4 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I thought the product was easy to use · 5 - Strongly Agree
|
18 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I think that I would need the support of a technical person to be able to use this product · 1 - Strongly Disagree
|
22 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I think that I would need the support of a technical person to be able to use this product · 2 - Disagree
|
0 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I think that I would need the support of a technical person to be able to use this product · 3 - Neutral
|
1 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I think that I would need the support of a technical person to be able to use this product · 4 - Agree
|
0 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I think that I would need the support of a technical person to be able to use this product · 5 - Strongly Agree
|
1 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I found the various functions in this product were well integrated · 1 - Strongly Disagree
|
2 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I found the various functions in this product were well integrated · 2 - Disagree
|
2 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I found the various functions in this product were well integrated · 3 - Neutral
|
2 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I found the various functions in this product were well integrated · 4 - Agree
|
4 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I found the various functions in this product were well integrated · 5 - Strongly Agree
|
14 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I thought there was too much inconsistency in this product · 1 - Strongly Disagree
|
18 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I thought there was too much inconsistency in this product · 2 - Disagree
|
5 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I thought there was too much inconsistency in this product · 3 - Neutral
|
1 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I thought there was too much inconsistency in this product · 4 - Agree
|
0 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I thought there was too much inconsistency in this product · 5 - Strongly Agree
|
0 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I would imagine that most people would learn to use this product very quickly · 1 - Strongly Disagree
|
0 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I would imagine that most people would learn to use this product very quickly · 2 - Disagree
|
0 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I would imagine that most people would learn to use this product very quickly · 3 - Neutral
|
0 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I would imagine that most people would learn to use this product very quickly · 4 - Agree
|
1 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I would imagine that most people would learn to use this product very quickly · 5 - Strongly Agree
|
23 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I found the product very cumbersome to use · 1 - Strongly Disagree
|
11 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I found the product very cumbersome to use · 2 - Disagree
|
4 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I found the product very cumbersome to use · 3 - Neutral
|
5 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I found the product very cumbersome to use · 4 - Agree
|
1 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I found the product very cumbersome to use · 5 - Strongly Agree
|
3 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I felt very confident using the product · 1 - Strongly Disagree
|
0 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I felt very confident using the product · 2 - Disagree
|
0 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I felt very confident using the product · 3 - Neutral
|
0 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I felt very confident using the product · 4 - Agree
|
5 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I felt very confident using the product · 5 - Strongly Agree
|
19 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I needed to learn a lot of things before I could get going with this product · 1 - Strongly Disagree
|
15 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I needed to learn a lot of things before I could get going with this product · 2 - Disagree
|
3 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I needed to learn a lot of things before I could get going with this product · 3 - Neutral
|
2 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I needed to learn a lot of things before I could get going with this product · 4 - Agree
|
3 Participants
|
—
|
|
Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
I needed to learn a lot of things before I could get going with this product · 5 - Strongly Agree
|
1 Participants
|
—
|
Adverse Events
Furoscix Infusor Prospective Treatment
Serious events: 6 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Furoscix Infusor Prospective Treatment
n=24 participants at risk
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor outside the hospital.
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.
|
|---|---|
|
Cardiac disorders
Cardiac Failure Congestive
|
4.2%
1/24 • 30 Days from Enrollment
|
|
Gastrointestinal disorders
Food Poisoning
|
4.2%
1/24 • 30 Days from Enrollment
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
4.2%
1/24 • 30 Days from Enrollment
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
4.2%
1/24 • 30 Days from Enrollment
|
|
Metabolism and nutrition disorders
Hyperosmolar State
|
4.2%
1/24 • 30 Days from Enrollment
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
4.2%
1/24 • 30 Days from Enrollment
|
|
Renal and urinary disorders
Acute Kidney Injury
|
4.2%
1/24 • 30 Days from Enrollment
|
|
Renal and urinary disorders
Polyuria
|
4.2%
1/24 • 30 Days from Enrollment
|
|
Vascular disorders
Lymphedema
|
4.2%
1/24 • 30 Days from Enrollment
|
Other adverse events
| Measure |
Furoscix Infusor Prospective Treatment
n=24 participants at risk
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor outside the hospital.
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.
|
|---|---|
|
General disorders
Infusion Site Hemorrhage
|
8.3%
2/24 • 30 Days from Enrollment
|
|
General disorders
Infusion Site Bruising
|
29.2%
7/24 • 30 Days from Enrollment
|
|
General disorders
Infusion Site Pain
|
29.2%
7/24 • 30 Days from Enrollment
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
8.3%
2/24 • 30 Days from Enrollment
|
|
Infections and infestations
Urinary Tract Infection
|
8.3%
2/24 • 30 Days from Enrollment
|
|
Nervous system disorders
Dizziness
|
12.5%
3/24 • 30 Days from Enrollment
|
Additional Information
Sr. Vice President, Clinical Development and Medical Affairs
scPharmaceuticals
Phone: (855) 727 4276
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place