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

NCT ID: NCT03458325

Last Updated: 2023-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-12
• Study Completion Date: 2021-06-24

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. 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.

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-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.

Conditions

Heart Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Furoscix Infusor Prospective Treatment

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

Group Type: EXPERIMENTAL

Furoscix Infusor

Intervention Type: 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.

Propensity-Matched Historical Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Furoscix Infusor

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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 volume expansion, defined as one or more of the following:

1. jugular venous distention

2. pitting edema (≥1+),

3. abdominal distension

4. pulmonary congestion on chest x-ray

5. pulmonary rales

5. 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:

1. Oxygen saturation ≥ 90% on exertion

2. Respiratory Rate < 24 breaths per minute

3. Resting Heart Rate < 100 beats per minute

4. Systolic Blood Pressure > 100 mmHg

6. Adequate environment for at-home administration of Furoscix

Exclusion Criteria

1. Presence of a complicating condition, other than HF that requires immediate hospitalization or anticipated hospitalization in the next 30 days

2. Evidence of acute renal failure as determined at the discretion of the investigator

3. Known allergy to the active and inactive ingredients of the study medication or device adhesive

4. Any local abdominal skin condition on the day of treatment i.e. sunburn, rash, eczema, etc.

5. Currently participating in another interventional research study

6. Women who are pregnant or who could become pregnant and are not willing to use an adequate form of contraception

7. 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)

8. If baseline creatinine value is available: an increase of ≥ 0.5 mg/dL in creatinine from baseline

9. HF requiring immediate hospitalization

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

scPharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Olive View - UCLA Medical Center

Sylmar, California, United States

Bridgeport Hospital

Bridgeport, Connecticut, United States

Tampa General Hospital

Tampa, Florida, United States

Ascension St. Vincent Heart Center

Indianapolis, Indiana, United States

Unity Point Health

Des Moines, Iowa, United States

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Moses H. Cone Memorial Hospital

Greensboro, North Carolina, United States

Abington Hospital - Jefferson Health

Abington, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

scP-01-005

Identifier Type: -

Identifier Source: org_study_id