Heart Failure Clinical Trial
— FREEDOM-HFOfficial 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
Verified date | January 2023 |
Source | scPharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 27 |
Est. completion date | June 24, 2021 |
Est. primary completion date | June 24, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Abington Hospital - Jefferson Health | Abington | Pennsylvania |
United States | Bridgeport Hospital | Bridgeport | Connecticut |
United States | Unity Point Health | Des Moines | Iowa |
United States | Moses H. Cone Memorial Hospital | Greensboro | North Carolina |
United States | Ascension St. Vincent Heart Center | Indianapolis | Indiana |
United States | University of Minnesota Medical Center | Minneapolis | Minnesota |
United States | Olive View - UCLA Medical Center | Sylmar | California |
United States | Tampa General Hospital | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
scPharmaceuticals, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Heart-Failure Related Hospital Admissions | The HF-related admissions for the Furoscix patients compared to Control patients. | Day 0 - Day 30 | |
Secondary | All-Cause Hospital Admissions | The differences in the percentage of subjects with an all-cause hospitalization in the Furoscix group and all-cause 30-day rehospitalization in the Control group in the 30 day follow-up period | Day 0 - Day 30 | |
Secondary | Heart-Failure Related Emergency Department Visits | The differences in the percentage of patients with HF-related emergency department visits in the Furoscix group and in the Control group in the 30 day follow-up period | Day 0 - Day 30 | |
Secondary | Heart-Failure Related Clinic Visits | The differences in the percentage of patients with HF-related clinic visits in the Furoscix group and in the Control group in the 30 day follow-up period | Day 0 - Day 30 | |
Secondary | KCCQ-12 Scores | The Kansas City Cardiomyopathy Questionnaire (KCCQ) measures a patient's self-reported overall health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL). The KCCQ-12 overall summary score is the sum of responses from all 12 items ranging from 0 to 100 with higher scores to indicate better health status. | 30 Days | |
Secondary | Mean Change in NT-proBNP and BNP | Change in NT-proBNP and BNP change from baseline during the study period is summarized for the Furoscix group | Day 0 - Day 30 | |
Secondary | Comfort of Wear Questionnaire | The Furoscix group was administered a Comfort of Wear Questionnaire during Day 2-4 study visit. This questionnaire measured the patient's general perception of comfortability wearing and using the device, the impact of wearing the device on their activities of daily living, and their satisfaction with the device. | Day 0 - Day 2-4 study visit | |
Secondary | Comfort of Wear Questionnaire: Interference With Activities Daily Living | The Furoscix group was administered a Comfort of Wear Questionnaire on Day 2-4. This questionnaire measured the patient's general perception of comfortability wearing and using the device, the impact of wearing the device on their activities of daily living, and their satisfaction with the device. | Day 0 - Day 2-4 study visit | |
Secondary | Comfort of Wear Questionnaire: Subject and/or Caregiver Satisfaction | The Furoscix group was administered a Comfort of Wear Questionnaire during Day 2-4 study visit. This questionnaire measured the patient's general perception of comfortability wearing and using the device, the impact of wearing the device on their activities of daily living, and their satisfaction with the device. | Day 0 - Day 2-4 study visit |
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