- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03359161
Clinical Utility of Subcutaneous Furosemide in Patients Presenting With Early Signs of Fluid Overload
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Brighton, Massachusetts, United States, 02135
- St Elizabeth's Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age≥ 18 years
- Symptomatic and chronic heart failure (NYHA Class II and III).
- Patients on guideline directed medical therapy 90 days prior to enrollment.
- Adequate home environment for at-home treatment.
- Presenting or referred to the clinic because of evidence of worsening heart failure with fluid overload (decompensation).
- A modification in oral diuretics is not clinically appropriate as deemed by the investigator.
- Estimated excess fluid weight of 4 lbs. or more from euvolemic state.
- Participant able to give informed consent for participation in trial. Agreeing to sign informed consent and HIPAA authorization.
- Understanding and willing to comply with the protocols of the trial.
- Ability of the participant or caregiver to independently apply the investigational device and medication
Exclusion Criteria:
- ACC/AHA Stage D heart failure or patients requiring IV inotrope therapy.
- Massive volume overload (e.g. >20 lbs. of estimated fluid weight) or anasarca.
- Suspected high risk clinical instability with outpatient treatment.
- Pregnant females or women of child-bearing age who are not willing to use an adequate form of contraception.
- Chronic Obstructive Pulmonary Disease (COPD) moderate or worse: FEV1/FCV ratio <0.7 and FEV1 <60 percent predicted.
- Rapid atrial fibrillation (AF) (HR >100b/min)
- Hypoxia (resting O2 saturation <90%).
- Hypotension (systolic blood pressure (SBP) BP < 90 mmHg).
- Uncontrolled diabetes mellitus (DM) (admission glucose levels > 300 mg/dL).
- Advanced renal disease (eGFR < 30mL/min/1.73m2).
- Acute coronary syndrome.
- Serum potassium (K) <3.2 mmol/L or > 5.5mmol/L.
- On experimental medication or currently participating in an interventional cardiovascular research study, other than an observational or registry study.
- Having received intravenous furosemide within 24 hours prior to enrollment.
- Urinary tract abnormality or disorder interfering with urination.
- Allergy to the active and inactive ingredients of the study medication.
- Inability to comply with study requirements.
- Ongoing substance abuse.
- Concern that the current episode of decompensation was precipitated by a serious medical condition which may require additional evaluation or treatment.
- Dementia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Subcutaneous furosemide for the treatment of fluid overload
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight Change
Time Frame: 30 days
|
Weight change between enrollment/screening compared to last observation
|
30 days
|
Pro BNP Change
Time Frame: 30 days
|
Reduction in pro-BNP between enrollment/screening compared to last observation
|
30 days
|
Survival
Time Frame: 30 days
|
% of patients alive 30 days post enrollment
|
30 days
|
Hospital Admission for Heart Failure
Time Frame: 30 days
|
% of patients without hospitalization for worsening HF within 30 days after enrollment
|
30 days
|
Heart Failure Related Events
Time Frame: 30 days
|
% of patients without a significant Heart Failure related medical events within 30 days after enrollment.
|
30 days
|
Extra Furosemide Treatment
Time Frame: 7 days
|
Percentage of patients requiring additional 4 days of diuresis
|
7 days
|
Number of Participants That Discontinued Due to Presence of Skin Reaction to Drug or Device/Adhesive
Time Frame: 7 days
|
The number of participants that discontinued study participation due to the presence of a skin reaction to the drug or device/adhesive.
|
7 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lana Tsao, MD, St. Elizabeth's Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Clinical Protocol Version 4.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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