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Furoscix Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure (FREEDOM-HF)

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ClinicalTrials.gov Identifier: NCT03458325
Recruitment Status : Not yet recruiting
First Posted : March 8, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
scPharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Heart Failure Combination Product: Furoscix Infusor Phase 3

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 manual and patient video. 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Furoscix Infusor Prospective Treatment
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor outside the hospital.
Combination Product: 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.

No Intervention: 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.



Primary Outcome Measures :
  1. Difference in total HF-attributable direct medical costs [ Time Frame: 30 Days ]
    The difference in the overall cost of care between subjects treated with the Furoscix Infusor through 30 days post discharge from the emergency department versus matched controls treated in the hospital for ≤ 72 hours through 30 days post discharge.


Secondary Outcome Measures :
  1. Hospital admissions between the Furoscix Infusor arm and propensity-matched (treatment as usual) arm [ Time Frame: 30 Days ]
    To compare the Furoscix Infusor versus TAU with respect to number of hospital admissions and duration within 30 days post discharge from emergency department.

  2. HF-related hospital admissions between the Furoscix Infusor arm and propensity-matched (treatment as usual) arm [ Time Frame: 30 Days ]
    To compare the Furoscix Infusor versus TAU with respect to number of HF-related hospital admissions and duration within 30 days post discharge from emergency department.

  3. HF-related emergency department visits between the Furoscix Infusor arm and propensity-matched (treatment as usual) arm [ Time Frame: 30 Days ]
    To compare the Furoscix Infusor versus TAU with respect to number of HF-related emergency department visits within 30 days post discharge from emergency department.

  4. HF-related clinic visits between the Furoscix Infusor arm and propensity-matched (treatment as usual) arm [ Time Frame: 30 Days ]
    To compare the Furoscix Infusor versus TAU with respect to number of HF-related clinic visits within 30 days post discharge from emergency department.

  5. Health-related quality of life [ Time Frame: 30 Days ]
    Furoscix Infusor cohort complete twelve-item Kansas City Cardiomyopathy Questionnaire


Other Outcome Measures:
  1. Device Performance [ Time Frame: 30 Days ]
    Measurement of complete administration of Furoscix as prescribed.

  2. Participant Satisfaction of Device Performance [ Time Frame: 30 Days ]
    Furoscix Infusor cohort complete custom Comfort of Wear Questionnaire.

  3. Incidence of Treatment-Emergent Adverse Events or Serious Adverse Events [ Time Frame: 30 Days ]
    Furoscix Infusor cohort monitored for adverse events.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Responsible Party: scPharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03458325     History of Changes
Other Study ID Numbers: scP-01-005
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases