Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03458325 | Furoscix Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure | PHASE3 | COMPLETED | 27 | — | — | Nov 12, 2020 | Jun 24, 2021 | Feb 24, 2023 | 8 | United States |
| NCT04593823 | Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failure - A Pilot Study | PHASE2 | COMPLETED | 63 | — | — | May 3, 2021 | Apr 18, 2022 | Aug 1, 2023 | 18 | United States |
The difference in the overall and heart failure related healthcare costs between subjects treated with the Furoscix Infusor through 30 days post discharge from the emergency department compared to matched controls treated in the hospital for ≤ 72 hours through 30 days post discharge.
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.
Total number of CV deaths between two groups
Heart Failure hospitalizations compared between two groups
Urgent ED/Clinic visits for worsening heart failure compared between two groups. Statistical analysis was not performed due to no ED/Clinic visits
Percentage change in NT-proBNP from baseline at Day 7 compared between two groups
| Arm | Type | Description |
|---|---|---|
| Furoscix Infusor Prospective Treatment | EXPERIMENTAL | Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor outside the hospital. |
| Propensity-Matched Historical Control | NO_INTERVENTION | The control arm will be populated with claims data for patients with HF and fluid overload who presented to the emergency department and were admitted to the hospital for ≤ 72 hours for the treatment of HF with intravenous diuretics. Patients admitted for diuresis-only will be identified by using diagnostic codes for admittance from a claims database. |
| 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). |
| Continued Medical Therapy | NO_INTERVENTION | The subjects enrolled in this arm will receive treatment as usual |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: 1. Age 18-80 years 2. NYHA Class II-III HF presenting to the emergency department for worsening HF at baseline 3. On background therapy includes those receiving 40-160 mg of oral furosemide equivalents daily (20-80 mg Torsemide or 1-4 mg Bumetanide). 4. Signs of extracellular vo...