Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failure - A Pilot Study (AT HOME-HF)
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
Subjects are eligible for inclusion only if all the following criteria are met:
- Age 18 years or older.
- Diagnosis of symptomatic chronic heart failure (NYHA Class II-IV) with background loop diuretic therapy for at least 4 weeks.
- Need for augmented diuresis outside of the acute care setting as determined by the investigator.
- On background therapy including daily total furosemide equivalent dose (40-160 mg) of loop diuretic or equivalent.
The subject must have signs of volume expansion, defined as two or more of the following six signs:
- jugular venous distention
- edema (≥ 1+)
- ascites
- pulmonary congestion on chest x-ray
- pulmonary rales
- NT-proBNP ≥1000 pg/ml (1400 for patients in atrial fibrillation) or, for patients not on Entresto, BNP ≥200 (400 for patients in atrial fibrillation)
Increase over the preceding 30 days in at least one of the following symptoms characteristic of worsening heart failure:
- dyspnea
- fatigue
- exercise intolerance
- Adequate environment for at home administration of Furoscix by patient or caregiver.
Exclusion Criteria:
A Subject is not eligible for inclusion if any of the following criteria apply:
- Suspected high risk clinical instability with outpatient treatment.
- Presence of a complicating condition, other than heart failure likely to require hospitalization in next 30 days.
- Pregnant women or women of childbearing age who are not willing to use an adequate form of contraception.
- Known allergy to the active and inactive ingredients of the study medication or device adhesive.
- On experimental medication or currently participating in another interventional research study.
- eGFR < 20
- Serum potassium at baseline > 5.4 or < 3.6
- Concomitant infection
- Heart rate > 110
- Received IV furosemide or bumetanide within last 24 hours
Sites / Locations
- Heart Group of Eastern Shore
- The Heart Center Research, LLC
- Hartford Hospital
- Aventura Clinical Research, LLC
- University of Florida
- Elite Cardiac Research
- First Coast Cardiovascular Institute
- Cardiology Consultants
- James A. Haley Veerans Hospital
- University Hospital - Augusta
- Advocate Health and Hospitals
- UnityPoint Health - Methodist Hospital
- Michigan Heart
- St. Louis Heart and Vascular
- Icahn School of Medicine at Mount Sinai
- Cone Health Medical Group
- Lancaster General Hospital
- University of Wisconsin
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Furoscix Infusor
Continued Medical Therapy
Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours).
The subjects enrolled in this arm will receive treatment as usual