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NCT04593823 · ClinicalTrials.gov registry record · Phase 2
Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failure - A Pilot Study
A Phase 2 study, sponsored by scPharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
NCT04593823: Completed Phase 2 study, sponsored by scPharmaceuticals.
NCT04593823 is a Phase 2 study that has completed, run by scPharmaceuticals. The registered enrollment target is 63 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04593823, a Phase 2 study, has completed, sponsored by scPharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
Study 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
Primary Outcome
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.
Interventions
- COMBINATION_PRODUCT Furoscix Infusor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2021-05-03 |
| Est. Completion | 2022-04-18 |
| Phase | Phase 2 |
What the finished NCT04593823 record still lists
NCT04593823 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which Furoscix Infusor is the first listed.
NCT04593823 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04593823 about?
NCT04593823 is a clinical study titled "Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failure - A Pilot Study". 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...
What is the current status of trial NCT04593823?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2021-05-03. Estimated completion is 2022-04-18.
What interventions are being tested in trial NCT04593823?
The interventions under investigation include: Furoscix Infusor (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04593823?
This trial is sponsored by scPharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04593823's enrollment target sits among peer trials
63 1009th of 2000 higher than 985 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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