Trial · NCT04593823

Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failure - A Pilot Study

NCT04593823, Phase 2, Completed, scPharmaceuticals, Inc.; results first posted 2023-08-01

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failure - A Pilot Study. Trials, record NCT04593823. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04593823

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failure - A Pilot Study
NCT number: NCT04593823
Status: Completed
Phases: Phase 2
Enrollment: 63 participants, actual
Lead sponsor: scPharmaceuticals, Inc.
Conditions: Heart Failure
Interventions: Furoscix Infusor
First posted: 2020-10-20
Last updated: 2023-08-01
Results first posted: 2023-08-01

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Win Ratio of Composite Endpoint	Day 7, Day 30	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.
Primary	Number of Cardiovascular Deaths	Baseline, 30 Days	Total number of CV deaths between two groups
Primary	Number of Heart Failure Hospitalizations	30 Days	Heart Failure hospitalizations compared between two groups
Primary	Number of Urgent ED/Clinic Visits for Worsening Heart Failure	30 Days	Urgent ED/Clinic visits for worsening heart failure compared between two groups. Statistical analysis was not performed due to no ED/Clinic visits
Primary	NT-proBNP Change From Baseline	30 Days	Percentage change in NT-proBNP from baseline at Day 7 compared between two groups
Secondary	Number of Heart Failure Event Free Survival Days	30 Days	Out of 30 days, HF event-free survival is the average number of days subjects survived outside the hospital event-free.
Secondary	Number of Subjects Deceased or HF Event Occurred	30 Days	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.
Secondary	Visual Analog Scale (VAS)	Baseline, 7 Days, 30 Days	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.
Secondary	Composite Congestion Score (CCS)	Baseline, Day 7, Day 30	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.
Secondary	5-Point Current Dyspnea Score	Baseline, Day 7, Day 30	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)

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Win Ratio of Composite Endpoint	Day 7, Day 30	All randomized subjects	Number of Wins for the group	NUMBER
PRIMARY	Number of Cardiovascular Deaths	Baseline, 30 Days	All randomized subjects	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Heart Failure Hospitalizations	30 Days	All randomized subjects	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Urgent ED/Clinic Visits for Worsening Heart Failure	30 Days	All randomized subjects	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	NT-proBNP Change From Baseline	30 Days	All randomized subjects	percentage change from baseline (pg/mL)	MEDIAN
SECONDARY	Number of Heart Failure Event Free Survival Days	30 Days	All randomized subjects	days	MEAN
SECONDARY	Number of Subjects Deceased or HF Event Occurred	30 Days	All randomized subjects	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Visual Analog Scale (VAS)	Baseline, 7 Days, 30 Days	All randomized subjects	score on a scale	MEAN
SECONDARY	Composite Congestion Score (CCS)	Baseline, Day 7, Day 30	All randomized subjects	score on a scale	MEAN
SECONDARY	5-Point Current Dyspnea Score	Baseline, Day 7, Day 30	All randomized subjects	score on a scale	MEAN

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group122

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Win Ratio of Composite Endpoint	Furoscix Infusor		228	Number of Wins for the group
Win Ratio of Composite Endpoint	Continued Medical Therapy		206	Number of Wins for the group
Number of Cardiovascular Deaths	Furoscix Infusor	No	33	Participants
Number of Cardiovascular Deaths	Continued Medical Therapy	No	17	Participants
Number of Cardiovascular Deaths	Furoscix Infusor	Yes	1	Participants
Number of Cardiovascular Deaths	Continued Medical Therapy	Yes	0	Participants
Number of Heart Failure Hospitalizations	Furoscix Infusor	No	29	Participants
Number of Heart Failure Hospitalizations	Continued Medical Therapy	No	13	Participants
Number of Heart Failure Hospitalizations	Furoscix Infusor	Yes	5	Participants
Number of Heart Failure Hospitalizations	Continued Medical Therapy	Yes	4	Participants

1 to 10 of 122Source ClinicalTrials.gov

See all 122 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Furoscix Infusor	34
Overall Study	STARTED	Continued Medical Therapy	17
Overall Study	COMPLETED	Furoscix Infusor	33
Overall Study	COMPLETED	Continued Medical Therapy	15
Overall Study	NOT COMPLETED	Furoscix Infusor	1
Overall Study	NOT COMPLETED	Continued Medical Therapy	2

Source ClinicalTrials.gov

Adverse events64

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Cardiac failure congestive	Cardiac disorders	Furoscix Infusor	4	34
other	Cardiac failure congestive	Cardiac disorders	Continued Medical Therapy	0	17
other	Hypokalaemia	Metabolism and nutrition disorders	Furoscix Infusor	7	34
other	Hypokalaemia	Metabolism and nutrition disorders	Continued Medical Therapy	0	17
other	Hyperglycaemia	Metabolism and nutrition disorders	Furoscix Infusor	1	34
other	Hyperglycaemia	Metabolism and nutrition disorders	Continued Medical Therapy	1	17
other	Hypomagnesaemia	Metabolism and nutrition disorders	Furoscix Infusor	0	34
other	Hypomagnesaemia	Metabolism and nutrition disorders	Continued Medical Therapy	1	17
other	Infusion site pain	General disorders	Furoscix Infusor	5	34
other	Infusion site pain	General disorders	Continued Medical Therapy	0	17

1 to 10 of 64Source ClinicalTrials.gov

See all 64 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Furoscix Infusor	2	34
Total, all-cause mortality	Continued Medical Therapy	1	17
Total, other adverse events	Furoscix Infusor	23	34
Total, other adverse events	Continued Medical Therapy	9	17
Total, serious adverse events	Furoscix Infusor	12	34
Total, serious adverse events	Continued Medical Therapy	4	17

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39269392	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Furoscix Infusor vs Continued Medical Therapy: deaths from any cause	Trial comparisons
Furoscix Infusor vs Continued Medical Therapy: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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