Phase 3
N=25
Furoscix Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT03458325 ↗Enrolled (actual)
25
Serious AEs
25.0%
Results posted
Feb 2023
Primary outcome: Primary: Healthcare Utilization Costs — 2920.30; 7512.30 US Dollars — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Furoscix Infusor (Combination_product)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- scPharmaceuticals, Inc.
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Healthcare Utilization Costs |
2920.30; 7512.30 | <0.0001 sig |
| SECONDARY Heart-Failure Related Hospital Admissions |
1 | 0.6765 |
| SECONDARY All-Cause Hospital Admissions |
6 | 0.5856 |
| SECONDARY Heart-Failure Related Emergency Department Visits |
1; 4 | 1.000 |
| SECONDARY Heart-Failure Related Clinic Visits |
24 | <0.0001 sig |
| SECONDARY KCCQ-12 Scores |
29.9; 42.8; 37.1; 43.7; 33.1; 50.5 | 0.0443 sig |
| SECONDARY Mean Change in NT-proBNP and BNP |
823.4; 700.7; 785.1; 263.5 | 0.5133 |
| SECONDARY Comfort of Wear Questionnaire |
6; 9; 3; 0; 5; 1 | — |
| SECONDARY Comfort of Wear Questionnaire: Interference With Activities Daily Living |
19; 1; 1; 1; 1; 1 | — |
| SECONDARY Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction |
0; 2; 7; 2; 13; 14 | — |
Summary
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:
1. To evaluate differences in healthcare resource utilization and direct medical costs for patients treated with the Furoscix Infusor outside the hospital versus patients receiving intravenous furosemide for ≤ 72 hours in the hospital setting for 30 days post-discharge from the emergency department.
2. To evaluate the safety of Furoscix administered outside the hospital.
3. To evaluate and describe quality of life and patient satisfaction for patients who receive the Furoscix Infusor outside the hospital setting.
Eligibility Criteria
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:
- jugular venous distention
- pitting edema (≥1+),
- abdominal distension
- pulmonary congestion on chest x-ray
- pulmonary rales
- 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:
- Oxygen saturation ≥ 90% on exertion
- Respiratory Rate 100 mmHg
- 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
Data sourced from ClinicalTrials.gov (NCT03458325). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.