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NCT number NCT03359161
Study type Interventional
Source Steward St. Elizabeth's Medical Center of Boston, Inc.
Contact Margaret Michaelian, MD
Phone 6177893041
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date January 2018
Completion date June 2019

Clinical Trial Summary

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.

Clinical Trial Description

Investigational Product: Furosemide Injection, 8 mg/mL, (total dose =80 mg) administered subcutaneously by the sc2Wear Furosemide Infusor using a biphasic profile with 30 mg over the first hour and then as 12.5 mg per hour over the subsequent 4 hours. Participants may be prescribed a total of 3 days initial treatment followed by an optional additional 4 days of sc2Wear furosemide treatment based on initial clinical response.

Study Objectives: 1.) Evaluate the clinical effect of sc2Wear furosemide Infusor in the in-home management of mild to moderate decompensated heart failure.

2.) Evaluate the safety and tolerability of sc2Wear furosemide Infusor in the in-home management of mild to moderate decompensated heart failure.

Screening Phase:

The cardiology service will screen patients with mild to moderate fluid overload. Patients who present with other serious or life threatening condition for which hospitalization would be indicated are excluded. Women of child bearing potential will be screened for pregnancy with a urine pregnancy test. Eligible participants will be educated on device preparation, placement, removal and care in accordance with the Instructions of Use Manual. The screening phase includes evaluation of the home situation to ascertain that sufficient support is or can be made available for at home treatment as an alternative to inpatient care. In appropriate settings, lay caregiver will also be trained.

Pilot Phase. Patients will be visited daily by Steward Home Care and Hospice for home health nursing services in accordance with standard procedures. Nursing services will include checking vitals, obtaining blood samples and evaluation for clinical improvement or worsening. The first visit will be performed within 24 hours after enrollment.

Study Procedures: The first sc2Wear Infusor will be prepared and placed on the patient as part of the training. The patient will go home with the sc2Wear furosemide Infusor in place on the abdomen to be activated upon arrival at home. Participants will be treated with the sc2Wear furosemide Infusor daily for 3 consecutive days at home. Participants will be evaluated by the cardiology service of SEMC within 24 hours after the 3rd dose of sc2Wear furosemide. If a patient was found to have responded satisfactorily but requires additional parenteral diuretics an additional 4 days may be prescribed for a total of 7 consecutive treatments. If additional units are prescribed patients are to be evaluated the cardiology service of SEMC within 24 hours after the last dose of sc2Wear furosemide Infusor. If the subject requires further parenteral diuresis after the 7 days of at home treatment, they will be converted to usual care at that time, which may require inpatient care. Participants will be instructed to record daily morning weights during and after treatment until the second post treatment evaluation. Interim clinic visits and laboratory assessments may be required based on clinical considerations.

The following parameters will be studied at Baseline and follow-up treatment visits.

- Body Weight

- Vital signs

- HF Physical examination

- Dyspnea scale

- Routine laboratory panel (incl. electrolyte, pro-BNP)

- Adverse events

- Injection site assessment Participants will visit the clinic 30 ± 3 days after the start of the study for a post treatment evaluation.

Study Design

Related Conditions & MeSH terms

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