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The study is to evaluate the safe admission avoidance and the overall economic impact associated with management of worsening HF using the drug-device combination product, the Furoscix Infusor, outside the hospital setting in patients initially presenting to the emergency department.
The study drug, Furoscix (furosemide injection 8 mg/ml), is a furosemide solution buffered to a neutral pH containing 80 mg/10 mL for subcutaneous administration over 5 hours via the Furoscix Infusor.
The study objectives are:
This adaptive clinical trial will include a prospective treatment arm (i.e., Furoscix administered via the Furoscix Infusor) administered outside the hospital that will be compared to a propensity-matched historical control arm of patients admitted to the hospital for ≤ 72 hours (i.e., Treatment As Usual (TAU)) that will be derived from administrative claims data. Eligible patients for the Furoscix arm will be patients with HF and fluid overload who initially present to the emergency department (ED) and who are expected to require parenteral diuresis.
If it is determined by the investigator that the patient requires parenteral diuresis or continued diuresis outside of the ED care setting and meets all study eligibility criteria, he/she may be consented and enrolled into the study.
The treatment comprises a preprogrammed bi-phasic 5-hour drug administration. Subjects will be instructed on the use of the Furoscix Infusor by the investigator and/or study staff in accordance with the instructions for use. The initial dose of the study product may be administered in the ED or at home. Additional doses will be provided to the subject for self-administration or administration by a caregiver in the home setting as directed by the investigator or study staff. The total duration in days and total number of doses of the initial therapy will be determined by the investigator based on an estimated volume of diuresis desired to transition patient back to their oral diuretic maintenance therapy. Subjects will receive scheduled at-home telephone calls from a HF nurse on Days 1 and 7 and one call between Days 14-21. Planned in-clinic visits will be conducted between Day 2-4 and then Day 30. Unscheduled at-home telephone calls by a HF nurse and unscheduled in-clinic visits may be performed if felt clinically indicated by the study team or the clinical provider.
The study period will be up to 30 days after enrollment. All outcomes will be assessed up to 30 days after the initial discharge from the emergency department.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Furoscix Infusor Prospective Treatment | Experimental | Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor outside the hospital. |
|
| Propensity-Matched Historical Control | No Intervention | The control arm will be populated with claims data for patients with HF and fluid overload who presented to the emergency department and were admitted to the hospital for ≤ 72 hours for the treatment of HF with intravenous diuretics. Patients admitted for diuresis-only will be identified by using diagnostic codes for admittance from a claims database. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furoscix Infusor | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare Utilization Costs | 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. | Day 0 - Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Heart-Failure Related Hospital Admissions | The HF-related admissions for the Furoscix patients compared to Control patients. | Day 0 - Day 30 |
| All-Cause Hospital Admissions | 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 |
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Inclusion Criteria:
Age 18-80 years
NYHA Class II-III HF presenting to the emergency department for worsening HF at baseline
On background therapy includes those receiving 40-160 mg of oral furosemide equivalents daily (20-80 mg Torsemide or 1-4 mg Bumetanide).
Signs of extracellular volume expansion, defined as one or more of the following:
After initial emergency department evaluation and treatment (i.e., at the time of the care transition decision*), candidates for parenteral diuresis outside of the hospital, defined as all the following:
Adequate environment for at-home administration of Furoscix
Exclusion Criteria:
Presence of a complicating condition, other than HF that requires immediate hospitalization or anticipated hospitalization in the next 30 days
Evidence of acute renal failure as determined at the discretion of the investigator
Known allergy to the active and inactive ingredients of the study medication or device adhesive
Any local abdominal skin condition on the day of treatment i.e. sunburn, rash, eczema, etc.
Currently participating in another interventional research study
Women who are pregnant or who could become pregnant and are not willing to use an adequate form of contraception
Estimated Creatinine Clearance < 30 mL per minute by Cockcroft-Gault equation
CrCl (mL/min) = {(140 - age) x Lean Body Weight (kg)/Serum Creatinine (mg/dL) x 72} (x 0.85 if female)
If baseline creatinine value is available: an increase of ≥ 0.5 mg/dL in creatinine from baseline
HF requiring immediate hospitalization
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Olive View - UCLA Medical Center | Sylmar | California | 91342 | United States | ||
| Bridgeport Hospital |
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2 subjects excluded after signing consent:
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Healthcare Utilization Costs | 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. | Posted | Mean | Standard Deviation | US Dollars | Day 0 - Day 30 |
|
30 Days from Enrollment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (23.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion Site Hemorrhage | General disorders | MedDRA (23.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Vice President, Clinical Development and Medical Affairs | scPharmaceuticals | (855) 727 4276 | jmohr@scpharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 2, 2021 | Nov 3, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 5, 2021 | Nov 3, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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A prospective treatment arm (i.e., Furoscix administered via the Furoscix Infusor) administered outside the hospital that will be compared to a propensity-matched historical control arm of patients admitted to the hospital for ≤ 72 hours (i.e., Treatment As Usual (TAU)) that will be derived from administrative claims data.
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| Day 0 - Day 30 |
| Heart-Failure Related Emergency Department Visits | 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 | Day 0 - Day 30 |
| Heart-Failure Related Clinic Visits | The 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 | Day 0 - Day 30 |
| KCCQ-12 Scores | 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. | 30 Days |
| Mean Change in NT-proBNP and BNP | Change in NT-proBNP and BNP change from baseline during the study period is summarized for the Furoscix group | Day 0 - Day 30 |
| Comfort of Wear Questionnaire | 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. | Day 0 - Day 2-4 study visit |
| Comfort of Wear Questionnaire: Interference With Activities Daily Living | 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. | Day 0 - Day 2-4 study visit |
| Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction | 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. | Day 0 - Day 2-4 study visit |
| Bridgeport |
| Connecticut |
| 06610 |
| United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Ascension St. Vincent Heart Center | Indianapolis | Indiana | 46260 | United States |
| Unity Point Health | Des Moines | Iowa | 50309 | United States |
| University of Minnesota Medical Center | Minneapolis | Minnesota | 55422 | United States |
| Moses H. Cone Memorial Hospital | Greensboro | North Carolina | 27401 | United States |
| Abington Hospital - Jefferson Health | Abington | Pennsylvania | 19001 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Subject's Insurance at baseline | Count of Participants | Participants |
|
| NYHA Classification | New York Heart Association Classification
| Count of Participants | Participants |
|
| Signs of volume expansion at baseline | Count of Participants | Participants |
|
| History of Congestive Heart Failure (CHF) | Mean | Standard Deviation | Years |
|
| Etiology of Congestive Heart Failure (CHF) at baseline | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Heart-Failure Related Hospital Admissions | The HF-related admissions for the Furoscix patients compared to Control patients. | Evaluable Population: | Posted | Count of Participants | Participants | Day 0 - Day 30 |
|
|
|
|
| Secondary | All-Cause Hospital Admissions | 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 | Evaluable Population | Posted | Count of Participants | Participants | Day 0 - Day 30 |
|
|
|
|
| Secondary | Heart-Failure Related Emergency Department Visits | 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 | Evaluable Population | Posted | Count of Participants | Participants | Day 0 - Day 30 |
|
|
|
|
| Secondary | Heart-Failure Related Clinic Visits | The 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 | Posted | Count of Participants | Participants | Day 0 - Day 30 |
|
|
|
|
| Secondary | KCCQ-12 Scores | 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. | Summary Score represents integration of Physical Limitation, Symptom Frequency, Quality of Life and Social Limitation Scores. Missing values were not included in this analysis | Posted | Mean | Standard Deviation | score on a scale | 30 Days |
|
|
|
|
| Secondary | Mean Change in NT-proBNP and BNP | Change in NT-proBNP and BNP change from baseline during the study period is summarized for the Furoscix group | Evaluable Population. Subjects who are missing the NT-proBNP and BNP test results were excluded from this analysis. | Posted | Mean | Standard Deviation | pg/ml | Day 0 - Day 30 |
|
|
|
|
| Secondary | Comfort of Wear Questionnaire | 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. | Evaluable Population | Posted | Count of Participants | Participants | Day 0 - Day 2-4 study visit |
|
|
|
| Secondary | Comfort of Wear Questionnaire: Interference With Activities Daily Living | 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. | Evaluable Population | Posted | Count of Participants | Participants | Day 0 - Day 2-4 study visit |
|
|
|
| Secondary | Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction | 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. | Evaluable Population | Posted | Count of Participants | Participants | Day 0 - Day 2-4 study visit |
|
|
|
| 0 |
| 24 |
| 6 |
| 24 |
| 18 |
| 24 |
| Food Poisoning | Gastrointestinal disorders | MedDRA (23.1) | Non-systematic Assessment |
|
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA (23.1) | Non-systematic Assessment |
|
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA (23.1) | Non-systematic Assessment |
|
| Hyperosmolar State | Metabolism and nutrition disorders | MedDRA (23.1) | Non-systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Non-systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | MedDRA (23.1) | Non-systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA (23.1) | Non-systematic Assessment |
|
| Lymphedema | Vascular disorders | MedDRA (23.1) | Non-systematic Assessment |
|
| Infusion Site Bruising | General disorders | MedDRA (23.1) | Non-systematic Assessment |
|
| Infusion Site Pain | General disorders | MedDRA (23.1) | Non-systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (23.1) | Non-systematic Assessment |
|
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| Physical Limitation Score |
|
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| Symptom Frequency Score |
|
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| Quality of Life Score |
|
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| Social Limitation Score |
|
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| BNP |
|
|
| t-test, 2 sided |
| 0.0420 |
| Mean Difference (Final Values) |
| -719.9 |
| 2-Sided |
| 95 |
| -1406.5 |
| -33.2 |
| Superiority |
| Neither Comfortable or Uncomfortable |
|
| Slightly Uncomfortable |
|
| Moderately Uncomfortable |
|
| Very Uncomfortable |
|
| Please rate how comfortable or uncomfortable you felt upon removal of the device |
|
| 4 - Probably |
|
| 5 - Completely |
|
| Not Applicable |
|
| If wearing the device interfered with activities of daily living - Standing |
|
| If wearing the device interfered with activities of daily living - Sitting reading watching TV |
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| If wearing the device interfered with activities of daily living - Lying down/napping |
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| If wearing the device interfered with activities of daily living - Using the bathroom |
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| If wearing the device interfered with activities of daily living - Driving or riding in a car |
|
| 4 - Agree |
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| 5 - Strongly Agree |
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| I found the product unnecessarily complex |
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| I thought the product was easy to use |
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| I think that I would need the support of a technical person to be able to use this product |
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| I found the various functions in this product were well integrated |
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| I thought there was too much inconsistency in this product |
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| I would imagine that most people would learn to use this product very quickly |
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| I found the product very cumbersome to use |
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| I felt very confident using the product |
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| I needed to learn a lot of things before I could get going with this product |
|