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

Stopped early · Phase 2/Phase 3

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT03359161

Run by

Steward St. Elizabeth's Medical Center of Boston, Inc.

People needed

9

Starts

2018-04-05

Expected to finish

2019-01-31

Last updated by the study team

2022-10-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• St ELizabeth's Medical Center — Brighton, Massachusetts, United States

Full record on ClinicalTrials.gov

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