Clinical Utility of Subcutaneous Furosemide in Patients Presenting With Early Signs of Fluid Overload
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|ClinicalTrials.gov Identifier: NCT03359161|
Recruitment Status : Recruiting
First Posted : December 2, 2017
Last Update Posted : April 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Combination Product: sc2Wear Furosemide Infusor||Phase 2 Phase 3|
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a prospective, open-label, descriptive two-phase study to evaluate the clinical effectiveness of a novel formulation of furosemide delivered by subcutaneous administration. Participants with mild to moderate signs of fluid overload will be included in the study. The study involves at home treatment with a novel formulation of subcutaneous furosemide. In the Pilot Phase (20 patients) will undergo 3 days of at home treatment for fluid overload. If determined to require more, will undergo an extra 4 days of treatment. The Investigator and her team will review the results for the first cohort and depending on the results will proceed to the Evaluation phase (40 patients).|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Descriptive Study to Evaluate the Clinical Utility of a Novel Formulation of Furosemide Delivered Subcutaneously in Patients Presenting With Early Signs of Fluid Overload|
|Actual Study Start Date :||April 5, 2018|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: In-Home Subcutaneous Furosemide Treatment ARm
Prospective, open-label arm to evaluate the clinical effectiveness of a novel formulation of furosemide delivered by subcutaneous administration.
Combination Product: sc2Wear Furosemide Infusor
Subcutaneous furosemide for the treatment of fluid overload
- % weight loss between enrollment/screening compared to Post Visit #1 and Post Visit #2 [ Time Frame: In between screening (day zero) and treatment (day 3 and or day 7) ]Weight loss
- Reduction in pro-BNP between enrollment/screening compared to Post Visit #1 and Post Visit #2 [ Time Frame: n between screening (day zero) and treatment (day 3 and or day 7) ]pro BNP change
- % of patients alive 30 days post enrollment [ Time Frame: 30 days ]Survival
- % of patients without hospitalization for worsening HF within 30 days after enrollment [ Time Frame: 30 days ]Hospital admission for heart failure
- % of patients without a significant Heart Failure related medical events within 30 days after enrollment. [ Time Frame: 30 days ]Heart failure related events
- Proportion of patients requiring additional 4 days of diuresis [ Time Frame: 7 days ]Extra furosemide treatment
- Discontinuation due to presence of skin reaction to drug or device/adhesive. [ Time Frame: 7 days ]adverse events
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03359161
|Contact: Margaret Michaelian, MD||6177893041||Margaret.Michaelian@steward.org|
|Contact: Maxwell E Afari, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|St ELizabeth's Medical Center||Recruiting|
|Brighton, Massachusetts, United States, 02135|
|Contact: Margaret Michaelian, MD 617-789-3041 email@example.com|
|Contact: Maxwell Afari, MD 6177893000 firstname.lastname@example.org|
|Principal Investigator:||Lana Tsao, MD||St Elizabeth's MEdical Center|