Phase 2
N=51
Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failure - A Pilot Study
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT04593823 ↗Enrolled (actual)
51
Serious AEs
31.4%
Results posted
Aug 2023
Primary outcome: Primary: Win Ratio of Composite Endpoint — 228; 206 Number of Wins for the group
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Furoscix Infusor (Combination_product)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- scPharmaceuticals, Inc.
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Win Ratio of Composite Endpoint |
228; 206 | — |
| PRIMARY Number of Cardiovascular Deaths |
33; 17; 1; 0 | >0.999 |
| PRIMARY Number of Heart Failure Hospitalizations |
29; 13; 5; 4 | 0.459 |
| PRIMARY Number of Urgent ED/Clinic Visits for Worsening Heart Failure |
34; 17; 0; 0 | — |
| PRIMARY NT-proBNP Change From Baseline |
-7.195; -2.170 | 0.547 |
| SECONDARY Number of Heart Failure Event Free Survival Days |
23.2; 14.3 | 0.336 |
| SECONDARY Number of Subjects Deceased or HF Event Occurred |
28; 13; 6; 4 | — |
| SECONDARY Visual Analog Scale (VAS) |
57.1; 48.8; 66.8; 59.7; 70.2; 60.7 | — |
| SECONDARY Composite Congestion Score (CCS) |
3.9; 3.7; 2.2; 2.6; 1.5; 2.1 | — |
| SECONDARY 5-Point Current Dyspnea Score |
1.3; 1.8; 0.8; 1.1; 0.9; 1.3 | — |
| SECONDARY 7-Point Dyspnea Score |
3; 1; 12; 0; 8; 4 | — |
| SECONDARY KCCQ-12 Summary Score |
40.96; 30.54; 51.55; 36.68; 55.80; 45.33 | — |
| SECONDARY Six-Minute Walk Test (6MWT) |
241.7; 177.6; 269.0; 201.0; 292.3; 192.3 | — |
| SECONDARY Percent Lung Fluid |
36.8; 34.5; 34.8; 31.3; 35.6; 34.4 | — |
| SECONDARY Body Weight |
112.563; 111.704; 110.748; 115.524; 109.935; 116.199 | — |
| SECONDARY Renal Function |
1.496; 1.696; 1.611; 1.894; 1.648; 1.811 | — |
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:
1. To provide pilot data on the effectiveness and safety to inform a pivotal trial.
2. To inform population enrichment strategies
3. To refine pivotal trial endpoints and analytical methods
4. To identify operational challenges of study design
5. To assess patient adherence, competence, and experience
6. To familiarize staff and patients with device application and use
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 5.4 or 110
- Received IV furosemide or bumetanide within last 24 hours
Data sourced from ClinicalTrials.gov (NCT04593823). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.