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.
| Condition | Heart failure, Congestive Heart Failure, Heart failure, Heart disease, Heart disease, Cardiac Disease, Congestive Heart Failure, Cardiac Disease, cardiac failure, congestive heart disease |
|---|---|
| Treatment | Furoscix Infusor |
| Clinical Study Identifier | NCT03458325 |
| Sponsor | scPharmaceuticals, Inc. |
| Last Modified on | 14 August 2022 |
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