A Multicenter, Randomized, Open Label, Controlled Study Evaluating the Effectiveness and Safety of Furoscix On-Body Infusor vs Continued Medical Therapy for Worsening Heart Failure
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- scPharmaceuticals, Inc.
- Enrollment
- 63
- Locations
- 18
- Primary Endpoint
- NT-proBNP Change From Baseline
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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
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.
Investigators
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+)
- •pulmonary congestion on chest x-ray
- •pulmonary rales
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.
- •Serum potassium at baseline \> 5.4 or \< 3.6
- •Concomitant infection
- •Heart rate \> 110
- •Received IV furosemide or bumetanide within last 24 hours
Outcomes
Primary Outcomes
NT-proBNP Change From Baseline
Time Frame: 30 Days
Percentage change in NT-proBNP from baseline at Day 7 compared between two groups
Number of Urgent ED/Clinic Visits for Worsening Heart Failure
Time Frame: 30 Days
Urgent ED/Clinic visits for worsening heart failure compared between two groups. Statistical analysis was not performed due to no ED/Clinic visits
Number of Cardiovascular Deaths
Time Frame: Baseline, 30 Days
Total number of CV deaths between two groups
Number of Heart Failure Hospitalizations
Time Frame: 30 Days
Heart Failure hospitalizations compared between two groups
Win Ratio of Composite Endpoint
Time Frame: Day 7, Day 30
Win Ratio calculated as number of pairs of Furoscix On-Body Infusor subject "wins" divided by number of pairs of Furoscix On-Body Infusor subject "losses" when compared to Continued Medical Therapy subjects. Components of Endpoint composite outcome: CV death, HF hospitalization, Urgent ED/Clinic visit at 30 days and percent change in NT-proBNP from baseline at Day 7. See Statistical Analysis Plan for detailed explanation of this statistical method.
Secondary Outcomes
- Number of Subjects Deceased or HF Event Occurred(30 Days)
- Composite Congestion Score (CCS)(Baseline, Day 7, Day 30)
- 7-Point Dyspnea Score(Baseline, Day 3, Day 7, Day 30)
- Number of Heart Failure Event Free Survival Days(30 Days)
- Visual Analog Scale (VAS)(Baseline, 7 Days, 30 Days)
- KCCQ-12 Summary Score(Baseline, 7 Days, 30 Days)
- Percent Lung Fluid(Baseline, Day 7, Day 30)
- 5-Point Current Dyspnea Score(Baseline, Day 7, Day 30)
- Six-Minute Walk Test (6MWT)(Baseline, 7 Days, 30 Days)
- Body Weight(Baseline, Day 3, Day 7, Day 30)
- Renal Function(Baseline, Day 3, Day 7, Day 30)