Avoiding Treatment in the Hospital With Furoscix for the... | NCT04593823

NCT04593823

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Furoscix Infusor	Experimental	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).	Combination Product: Furoscix Infusor
Continued Medical Therapy	No Intervention	The subjects enrolled in this arm will receive treatment as usual

Interventions

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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Win Ratio of Composite Endpoint	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.	Day 7, Day 30
Number of Cardiovascular Deaths	Total number of CV deaths between two groups	Baseline, 30 Days
Number of Heart Failure Hospitalizations	Heart Failure hospitalizations compared between two groups	30 Days
Number of Urgent ED/Clinic Visits for Worsening Heart Failure	Urgent ED/Clinic visits for worsening heart failure compared between two groups. Statistical analysis was not performed due to no ED/Clinic visits	30 Days
NT-proBNP Change From Baseline	Percentage change in NT-proBNP from baseline at Day 7 compared between two groups	30 Days

Secondary Outcomes

Measure	Description	Time Frame
Number of Heart Failure Event Free Survival Days	Out of 30 days, HF event-free survival is the average number of days subjects survived outside the hospital event-free.	30 Days
Number of Subjects Deceased or HF Event Occurred

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Marvin A Konstam, MD	Principal Investigator	Principal Investigator
James E Udelson, MD	Principal Investigator	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Heart Group of Eastern Shore		Fairhope	Alabama	36532	United States
The Heart Center Research, LLC

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39269392	Derived	Konstam MA, Massaro J, Dhingra R, Walsh M, Ordway L, Pursley MS, McLean DS, Saha S, Close N, Konstam JM, Luepke KH, Mohr JF, Udelson JE. Avoiding Treatment in Hospital With Subcutaneous Furosemide for Worsening Heart Failure: A Pilot Study (AT HOME-HF). JACC Heart Fail. 2024 Nov;12(11):1830-1841. doi: 10.1016/j.jchf.2024.07.015. Epub 2024 Sep 11.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 9, 2021	May 25, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

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.

Intention to Treat Population

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	Continued Medical Therapy	The subjects enrolled in this arm will receive Continued Medical Treatment as usual as per the investigator
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	OG000228 OG001206

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Win Ratio	1.11			2-Sided	95	0.48	2.50			A win ratio parameter signifies the percentage of wins that a treatment group has achieved when compared against a comparator.		Superiority

Primary

Number of Cardiovascular Deaths

Total number of CV deaths between two groups

All randomized subjects

Posted

Count of Participants

Participants

Baseline, 30 Days

ID	Title	Description
OG000	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.
OG001	Continued Medical Therapy	The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator

Units	Counts
Participants

Primary

Number of Heart Failure Hospitalizations

Heart Failure hospitalizations compared between two groups

All randomized subjects

Posted

Count of Participants

Participants

30 Days

ID	Title	Description
OG000	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.
OG001	Continued Medical Therapy	The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator

Units	Counts
Participants

Primary

Number of Urgent ED/Clinic Visits for Worsening Heart Failure

Urgent ED/Clinic visits for worsening heart failure compared between two groups.

Statistical analysis was not performed due to no ED/Clinic visits

All randomized subjects

Posted

Count of Participants

Participants

30 Days

ID	Title	Description
OG000	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.
OG001	Continued Medical Therapy	The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator

Units	Counts

Primary

NT-proBNP Change From Baseline

Percentage change in NT-proBNP from baseline at Day 7 compared between two groups

All randomized subjects

Posted

Median

Full Range

percentage change from baseline (pg/mL)

30 Days

ID	Title	Description
OG000	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.
OG001	Continued Medical Therapy	The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator

Units	Counts
Participants

Secondary

Number of Heart Failure Event Free Survival Days

Out of 30 days, HF event-free survival is the average number of days subjects survived outside the hospital event-free.

All randomized subjects

Posted

Mean

Standard Deviation

days

30 Days

ID	Title	Description
OG000	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.
OG001	Continued Medical Therapy	The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator

Units	Counts
Participants

Secondary

Number of Subjects Deceased or HF Event Occurred

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.

All randomized subjects

Posted

Count of Participants

Participants

30 Days

ID	Title	Description
OG000	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.
OG001	Continued Medical Therapy	The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator

Units	Counts

Secondary

Visual Analog Scale (VAS)

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.

All randomized subjects

Posted

Mean

Standard Deviation

score on a scale

Baseline, 7 Days, 30 Days

ID	Title	Description
OG000	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.
OG001	Continued Medical Therapy	The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator

Secondary

Composite Congestion Score (CCS)

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.

All randomized subjects

Posted

Mean

Standard Deviation

score on a scale

Baseline, Day 7, Day 30

ID	Title	Description
OG000	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.
OG001	Continued Medical Therapy	The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator

Secondary

5-Point Current Dyspnea Score

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)

All randomized subjects

Posted

Mean

Standard Deviation

score on a scale

Baseline, Day 7, Day 30

ID	Title	Description
OG000	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.
OG001	Continued Medical Therapy	The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator

Secondary

7-Point Dyspnea Score

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.

All randomized subjects

Posted

Count of Participants

Participants

Baseline, Day 3, Day 7, Day 30

ID	Title	Description
OG000	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.
OG001	Continued Medical Therapy	The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator

Secondary

KCCQ-12 Summary Score

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.

All randomized subjects

Posted

Mean

Standard Deviation

units on a scale

Baseline, 7 Days, 30 Days

ID	Title	Description
OG000	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.
OG001	Continued Medical Therapy	The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator

Secondary

Six-Minute Walk Test (6MWT)

Change from baseline in Six-Minute Walk Test (6MWT) across follow-up timepoints

All randomized subjects

Posted

Mean

Standard Deviation

meters

Baseline, 7 Days, 30 Days

ID	Title	Description
OG000	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.
OG001	Continued Medical Therapy	The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator

Units	Counts
Participants

Secondary

Percent Lung Fluid

Lung fluid volume as measured via Remote Dielectric Sensing (ReDS)

All randomized subjects

Posted

Mean

Standard Deviation

% Fluid Volume in Lungs

Baseline, Day 7, Day 30

ID	Title	Description
OG000	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.
OG001	Continued Medical Therapy	The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator

Units	Counts
Participants

Secondary

Body Weight

Body weight of the patient on the day of visit

All randomized subjects

Posted

Mean

Standard Deviation

Kilograms

Baseline, Day 3, Day 7, Day 30

ID	Title	Description
OG000	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.
OG001	Continued Medical Therapy	The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator

Units	Counts
Participants

Secondary

Renal Function

Change from baseline in serum creatinine

All randomized subjects

Posted

Mean

Standard Deviation

mg/dL

Baseline, Day 3, Day 7, Day 30

ID	Title	Description
OG000	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.
OG001	Continued Medical Therapy	The subjects enrolled in this arm received Continued Medical Treatment as usual as per the investigator

Units	Counts
Participants

Arm/Groups

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	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.	2	34	12	34	23	34
EG001	Continued Medical Therapy	The subjects enrolled in this arm received treatment as usual as per the investigator.	1	17	4	17	9	17

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac failure congestive	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0007 affected34 at risk EG0014 affected17 at risk
Left ventricular hypertrophy	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected17 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected17 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected17 at risk
Pneumonia	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected17 at risk
Urinary tract infection	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected17 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected17 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected17 at risk
Hypertensive crisis	Vascular disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected17 at risk
Shock haemorrhagic	Vascular disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected17 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected17 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected17 at risk
Sudden cardiac death	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected17 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected17 at risk
Syncope	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected17 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected17 at risk
Renal impairment	Renal and urinary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected17 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac failure congestive	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0004 affected34 at risk EG0010 affected17 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Non-systematic Assessment	EG0007 affected34 at risk EG0010 affected17 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected34 at risk EG0011 affected17 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected17 at risk
Infusion site pain	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG0005 affected34 at risk EG0010 affected17 at risk
Infusion site bruising	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected34 at risk EG0010 affected17 at risk
Asthenia	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected17 at risk
Renal impairment	Renal and urinary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0005 affected34 at risk EG0012 affected17 at risk
Nausea	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0003 affected34 at risk EG0010 affected17 at risk
Blood creatinine increased	Investigations	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected34 at risk EG0010 affected17 at risk
Pneumonia	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected34 at risk EG0011 affected17 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected34 at risk EG0011 affected17 at risk
Dizziness	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected17 at risk
Fatigue	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected34 at risk EG0012 affected17 at risk
Weight increase	Investigations	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected17 at risk

First MCP Posted Date

ID	Term
D006333	Heart Failure

Units	Counts
Participants	OG00034 OG00117

Units	Counts
Participants	OG00034 OG00117

Units	Counts
Participants	OG00034 OG00117

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases