Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failure - A Pilot Study
Public ClinicalTrials.gov record NCT04593823. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT04593823
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 63 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 3, 2021 (Actual)
- Primary completion
- Apr 18, 2022 (Actual)
- Completion
- Apr 18, 2022 (Actual)
- Last update posted
- Aug 1, 2023
2021 – 2022
United States locations
- U.S. sites
- 18
- U.S. states
- 11
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Heart Group of Eastern Shore | Fairhope | Alabama | 36532 | — |
| The Heart Center Research, LLC | Huntsville | Alabama | 35801 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| Aventura Clinical Research, LLC | Aventura | Florida | 33541 | — |
| University of Florida | Gainesville | Florida | 32611 | — |
| Elite Cardiac Research | Hialeah | Florida | 33012 | — |
| First Coast Cardiovascular Institute | Jacksonville | Florida | 32256 | — |
| Cardiology Consultants | Pensacola | Florida | 32501 | — |
| James A. Haley Veerans Hospital | Tampa | Florida | 33612 | — |
| University Hospital - Augusta | Augusta | Georgia | 30901 | — |
| Advocate Health and Hospitals | Downers Grove | Illinois | 60515 | — |
| UnityPoint Health - Methodist Hospital | Peoria | Illinois | 61606 | — |
| Michigan Heart | Ypsilanti | Michigan | 48197 | — |
| St. Louis Heart and Vascular | St Louis | Missouri | 63136 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Cone Health Medical Group | Greensboro | North Carolina | 27455 | — |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17602 | — |
| University of Wisconsin | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04593823, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 1, 2023 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04593823 live on ClinicalTrials.gov.