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Clinical trialNCT04593823CompletedPhase 2Interventional

Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failure - A Pilot Study

SponsorscPharmaceuticals, Inc.Enrollment63Heart Failure
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

18 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Heart Group of Eastern Shore

    Fairhope, Alabama, United States

  • the Heart Center Research, Llc

    Huntsville, Alabama, United States

  • Hartford Hospital

    Hartford, Connecticut, United States

  • Aventura Clinical Research, Llc

    Aventura, Florida, United States

  • University of Florida

    Gainesville, Florida, United States

  • Elite Cardiac Research

    Hialeah, Florida, United States

  • First Coast Cardiovascular Institute

    Jacksonville, Florida, United States

  • Cardiology Consultants

    Pensacola, Florida, United States

  • James A. Haley Veerans Hospital

    Tampa, Florida, United States

  • University Hospital - Augusta

    Augusta, Georgia, United States

  • Advocate Health and Hospitals

    Downers Grove, Illinois, United States

  • Unitypoint Health - Methodist Hospital

    Peoria, Illinois, United States

  • Michigan Heart

    Ypsilanti, Michigan, United States

  • St. Louis Heart and Vascular

    St Louis, Missouri, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, United States

  • Cone Health Medical Group

    Greensboro, North Carolina, United States

  • Lancaster General Hospital

    Lancaster, Pennsylvania, United States

  • University of Wisconsin

    Madison, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
3 May 2021
Primary completion
18 Apr 2022
Completion
18 Apr 2022
Last update posted
1 Aug 2023
Registered enrollment
63
Registry id
NCT04593823

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.