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Clinical trialNCT03359161TerminatedPhase 2/PHASE3Interventional

Clinical Utility of Subcutaneous Furosemide in Patients Presenting With Early Signs of Fluid Overload

SponsorSteward St. Elizabeth's Medical Center of Boston, Inc.Enrollment9Heart Failure
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This study will evaluate the usefulness of the subcutaneous administration of a new Lasix formulation. 20 patients will be evaluated in the first phase (pilot phase) and depending on the results, an additional 40 patients will be enrolled (Evaluation Phase). Patients with mild to moderate evidence of fluid overload who present to the cardiology service at St Elizabeth's Medical Center, Brighton, Massachusetts (SEMC) will be included in the study. Patients who qualify for thus study will be sent home with the sc2Wear™ Furosemide Infusor therapy for three days. This is a pump that patients place on their abdomen and it then delivers furosemide to the skin. Participants will be visited at home by a visiting nurse who will give them further teaching on the sc2Wear™ Furosemide Infusor. The visiting nurse will also be responsible for obtaining history (symptoms), physical examination (including inspecting the skin for adverse reactions related to the pump), and laboratory draws, supplementation of electrolytes as needed. Patients will be evaluated by the cardiology service of SEMC within 24 hours of the last dose of the sc2Wear™ Furosemide Infusor. If a patient is found to have satisfactorily responded but requires more therapy, an additional 4 days may be prescribed for total of seven consecutive treatments. If additional units are prescribed, patients will be evaluated by the cardiology service of SEMC within 24 hours of the last dose of the sc2Wear™ Furosemide infusion. Also an additionally, up to three-sc2Wear furosemide at home treatments may be used as authorized by the treating physician in case the patient experiences worsening heart failure within 30-days of enrollment (Rescue Treatment). Participants will be seen in clinic for follow up at 30±3 days after the start of the study for a post treatment.

Investigators

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

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Sites

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

United States
  • St Elizabeth'S Medical Center

    Brighton, Massachusetts, 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
5 Apr 2018
Primary completion
31 Jan 2019
Completion
31 Jan 2019
Last update posted
13 Oct 2022
Registered enrollment
9
Registry id
NCT03359161

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.