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Loop Diuretic

Furoscix Infusor for Heart Failure (AT HOME-HF Trial)

Phase 2
Waitlist Available
Led By Marvin A Konstam, MD
Research Sponsored by scPharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 3, day 7, day 30
Awards & highlights

Summary

This is a multicenter, randomized, open label, controlled study evaluating the effectiveness, and safety of the Furoscix Infusor vs continued medical therapy in patients with chronic heart failure and fluid overload requiring augmentation in diuretic therapy outside of acute care setting. 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: To provide pilot data on the effectiveness and safety to inform a pivotal trial. To inform population enrichment strategies To refine pivotal trial endpoints and analytical methods To identify operational challenges of study design To assess patient adherence, competence, and experience To familiarize staff and patients with device application and use

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 3, day 7, day 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 3, day 7, day 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
NT-proBNP Change From Baseline
Number of Cardiovascular Deaths
Number of Heart Failure Hospitalizations
+2 more
Secondary outcome measures
5-Point Current Dyspnea Score
7-Point Dyspnea Score
Body Weight
+8 more

Side effects data

From 2021 Phase 3 trial • 27 Patients • NCT03458325
29%
Infusion Site Bruising
29%
Infusion Site Pain
13%
Dizziness
8%
Infusion Site Hemorrhage
8%
Urinary Tract Infection
8%
Muscle Spasms
4%
Polyuria
4%
Tibia Fracture
4%
Diabetic Ketoacidosis
4%
Lymphedema
4%
Cardiac Failure Congestive
4%
Food Poisoning
4%
Hyperosmolar State
4%
Hypovolaemia
4%
Acute Kidney Injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
Furoscix Infusor Prospective Treatment

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Furoscix InfusorExperimental Treatment1 Intervention
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).
Group II: Continued Medical TherapyActive Control1 Intervention
The subjects enrolled in this arm will receive treatment as usual
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Furoscix Infusor
2021
Completed Phase 3
~90

Find a Location

Who is running the clinical trial?

scPharmaceuticals, Inc.Lead Sponsor
11 Previous Clinical Trials
346 Total Patients Enrolled
9 Trials studying Heart Failure
289 Patients Enrolled for Heart Failure
Marvin A Konstam, MDPrincipal InvestigatorPrincipal Investigator
1 Previous Clinical Trials
212 Total Patients Enrolled
1 Trials studying Heart Failure
212 Patients Enrolled for Heart Failure
James E Udelson, MDPrincipal InvestigatorPrincipal Investigator
~15 spots leftby Sep 2025
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