Status:
COMPLETED
Furoscix Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure
Lead Sponsor:
scPharmaceuticals, Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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, outsid...
Detailed Description
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-mat...
Eligibility Criteria
Inclusion
- 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 \< 24 breaths per minute
- Resting Heart Rate \< 100 beats per minute
- Systolic Blood Pressure \> 100 mmHg
- Adequate environment for at-home administration of Furoscix
Exclusion
- 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
Key Trial Info
Start Date :
November 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2021
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03458325
Start Date
November 12 2020
End Date
June 24 2021
Last Update
February 24 2023
Active Locations (8)
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1
Olive View - UCLA Medical Center
Sylmar, California, United States, 91342
2
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
3
Tampa General Hospital
Tampa, Florida, United States, 33606
4
Ascension St. Vincent Heart Center
Indianapolis, Indiana, United States, 46260