Furoscix Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure

NCT03458325 | Completed Phase 3 Results FDA Drug

• 1 other identifier: scP-01-005
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 8

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, 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. 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. 2.To evaluate the safety of Furoscix administered outside the hospital.
3. 3.To evaluate and describe quality of life and patient satisfaction for patients who receive the Furoscix Infusor outside the hospital setting.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Healthcare Utilization Costs

  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.

  Day 0 - Day 30

Secondary Outcomes (9)

• Heart-Failure Related Hospital Admissions

  Day 0 - Day 30

• All-Cause Hospital Admissions

  Day 0 - Day 30

• Heart-Failure Related Emergency Department Visits

  Day 0 - Day 30

• Heart-Failure Related Clinic Visits

  Day 0 - Day 30

• KCCQ-12 Scores

  30 Days

Study Arms (2)

Furoscix Infusor Prospective Treatment

EXPERIMENTAL

Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor outside the hospital.

Combination Product: Furoscix Infusor

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.

Interventions

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.

Furoscix Infusor Prospective Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• scPharmaceuticals, Inc.: lead

Study Sites (8)

Olive View - UCLA Medical Center

Sylmar, California, 91342, United States

Location

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Ascension St. Vincent Heart Center

Indianapolis, Indiana, 46260, United States

Location

Unity Point Health

Des Moines, Iowa, 50309, United States

Location

University of Minnesota Medical Center

Minneapolis, Minnesota, 55422, United States

Location

Moses H. Cone Memorial Hospital

Greensboro, North Carolina, 27401, United States

Location

Abington Hospital - Jefferson Health

Abington, Pennsylvania, 19001, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Sr. Vice President, Clinical Development and Medical Affairs
• Organization: scPharmaceuticals

jmohr@scpharma.com

(855) 727 4276

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 8, 2018
• Study Start: November 12, 2020
• Primary Completion: June 24, 2021
• Study Completion: June 24, 2021
• Last Updated: February 24, 2023
• Results First Posted: February 24, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)