Clinical trial NCT03458325: Furoscix Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure
Official title: Economic Impact of Reducing Hospital Admissions for Patients Presenting to the Emergency Department With Worsening Heart Failure: An Adaptive Clinical Trial of Furoscix Infusor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Lead sponsor: scPharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-08
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Healthcare Utilization Costs
timeFrame: Day 0 - Day 30
Secondary outcomes:
measure: Heart-Failure Related Hospital Admissions
timeFrame: Day 0 - Day 30
measure: All-Cause Hospital Admissions
timeFrame: Day 0 - Day 30
measure: Heart-Failure Related Emergency Department Visits
timeFrame: Day 0 - Day 30
measure: Heart-Failure Related Clinic Visits
timeFrame: Day 0 - Day 30
measure: KCCQ-12 Scores
timeFrame: 30 Days
measure: Mean Change in NT-proBNP and BNP
timeFrame: Day 0 - Day 30
measure: Comfort of Wear Questionnaire
timeFrame: Day 0 - Day 2-4 study visit
measure: Comfort of Wear Questionnaire: Interference With Activities Daily Living
timeFrame: Day 0 - Day 2-4 study visit
measure: Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction
timeFrame: Day 0 - Day 2-4 study visit
Other outcomes:
Locations:
city: Sylmar
country: United States
facility: Olive View - UCLA Medical Center
state: California
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Indianapolis
country: United States
facility: Ascension St. Vincent Heart Center
state: Indiana
city: Des Moines
country: United States
facility: Unity Point Health
state: Iowa
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Greensboro
country: United States
facility: Moses H. Cone Memorial Hospital
state: North Carolina
city: Abington
country: United States
facility: Abington Hospital - Jefferson Health
state: Pennsylvania
Study officials:
References: