AT HOME-HF: Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failure - A Pilot Study
Study Details
Study Description
Brief Summary
This is a multicenter, randomized, open label, controlled study evaluating the effectiveness, and safety of the Furoscix Infusor vs continued medical therapy in patients with chronic heart failure and fluid overload requiring augmentation in diuretic therapy outside of acute care setting.
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:
-
To provide pilot data on the effectiveness and safety to inform a pivotal trial.
-
To inform population enrichment strategies
-
To refine pivotal trial endpoints and analytical methods
-
To identify operational challenges of study design
-
To assess patient adherence, competence, and experience
-
To familiarize staff and patients with device application and use
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The purpose of this study is to evaluate the effectiveness and safety of the Furoscix Infusor vs continued medical therapy in patients with chronic heart failure and fluid overload requiring augmentation in diuretic therapy outside of acute care setting. 51 patients will be randomly assigned (2:1) to receive Furoscix vs continued medical therapy.
The Treatment Phase comprises a pre-programmed bi-phasic 5-hour drug administration of Furoscix (80 mg/10 mL) via the On-body Infusor. Subjects and/or their caregivers will be trained on device preparation, placement and removal in accordance with product instructions of use (IFU). Subjects should be transitioned back to their oral maintenance diuretic regimen when clinically indicated at the discretion of the investigator.
Over the initial 7 days, all subjects will receive daily clinic or phone follow-up by the study staff. Decision of treatment with Furoscix in the intervention arm as well as changes in oral diuretic dosing in the control arm will be determined by the treating physician in coordination with the study nurse. Safety labs will be done on Days 1, 3, 7 and 30.
After Subjects have been transitioned to their oral maintenance diuretic regimen, additional doses of Furoscix (for Furoscix group) or IV diuretics (for Treat as Usual group) can be prescribed during the 30-day study period as needed based on the presence of congestion symptoms (e.g. dyspnea, edema, and/or excess weight gain) as determined by the investigator.
The Follow-Up Phase will include a visit to the clinic on Day 30 +/- 5 days where effectiveness and safety assessments will be performed including limited physical exam (including NYHA Class), Composite Congestion Score (CCS), 5-point Current Dyspnea Score, 7-point Dyspnea Score, vital signs, laboratory analyses, KCCQ-12, Visual Analog Score (VAS), 6MWT and adverse events.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Furoscix Infusor 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). |
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: Continued Medical Therapy The subjects enrolled in this arm will receive treatment as usual |
Outcome Measures
Primary Outcome Measures
- Compare the Cardiovascular death hierarchically using Finkelstein-Schoenfeld Method. [30 Days]
Cardiovascular deaths will be compared to all other patients at 30 days
- Compare the Heart Failure hospitalization hierarchically using Finkelstein-Schoenfeld Method. [30 Days]
Heart Failure hospitalizations will be compared to all other patients at 30 days
- Compare the Urgent ED/Clinic visits for worsening heart failure hierarchically using Finkelstein-Schoenfeld Method. [30 Days]
Urgent ED/Clinic visits will be compared to all other patients at 30 days
- Compare NT-proBNP for worsening heart failure hierarchically using Finkelstein-Schoenfeld Method. [30 Days]
Change in NT-proBNP from baseline at Day 7 will be compared to all other patients at 30 days
Secondary Outcome Measures
- Days alive and heart failure event-free days [30 Days]
Hospitalization for heart failure or ED visits for heart failure over 30 days
- Change in patient global assessment via visual analog scale (VAS) [30 Days]
Change from baseline in patient global assessment via visual analog scale (VAS) across follow-up timepoints
- Change in composite congestion score (CCS) [30 Days]
Change from baseline in composite congestion score (CCS) across follow-up timepoints
- Change in 5-point Current Dyspnea Score [30 Days]
Change from baseline in 5-point Current Dyspnea Score across follow-up timepoints
- 7-point Dyspnea Score across follow-up time points [30 Days]
Change from baseline in 7-point Dyspnea Score across follow-up time points
- Health-related quality of life across follow-up time points [30 Days]
Change from baseline in health-related quality of life across follow-up timepoints
- Serum creatinine across follow-up time points [30 Days]
Change from baseline in serum creatinine across follow-up timepoints
- Ambulatory body weight across follow-up time points [30 Days]
Change from baseline in ambulatory body weight across follow-up timepoints
- Six-Minute Walk Test (6MWT) across follow-up time points [30 Days]
Change from baseline in Six-Minute Walk Test (6MWT) across follow-up timepoints
- % Lung Fluid Measurement across follow-up time points [30 Days]
Change from baseline in % Lung Fluid Measurement across follow-up timepoints
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Heart Group of Eastern Shore | Fairhope | Alabama | United States | 36532 |
| 2 | The Heart Center Research, LLC | Huntsville | Alabama | United States | 35801 |
| 3 | Hartford Hospital | Hartford | Connecticut | United States | 06102 |
| 4 | Aventura Clinical Research, LLC | Aventura | Florida | United States | 33541 |
| 5 | University of Florida | Gainesville | Florida | United States | 32611 |
| 6 | Elite Cardiac Research | Hialeah | Florida | United States | 33012 |
| 7 | First Coast Cardiovascular Institute | Jacksonville | Florida | United States | 32256 |
| 8 | Cardiology Consultants | Pensacola | Florida | United States | 32501 |
| 9 | James A. Haley Veerans Hospital | Tampa | Florida | United States | 33612 |
| 10 | University Hospital - Augusta | Augusta | Georgia | United States | 30901 |
| 11 | Advocate Health and Hospitals | Downers Grove | Illinois | United States | 60515 |
| 12 | UnityPoint Health - Methodist Hospital | Peoria | Illinois | United States | 61606 |
| 13 | Michigan Heart | Ypsilanti | Michigan | United States | 48197 |
| 14 | St. Louis Heart and Vascular | Saint Louis | Missouri | United States | 63136 |
| 15 | Icahn School of Medicine at Mount Sinai | New York | New York | United States | 10029 |
| 16 | Cone Health Medical Group | Greensboro | North Carolina | United States | 27455 |
| 17 | Lancaster General Hospital | Lancaster | Pennsylvania | United States | 17602 |
| 18 | University of Wisconsin | Madison | Wisconsin | United States | 53792 |
Sponsors and Collaborators
- scPharmaceuticals, Inc.
Investigators
- Principal Investigator: Marvin A Konstam, MD, Principal Investigator
- Principal Investigator: James E Udelson, MD, Principal Investigator
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- scP-01-008