Status:
TERMINATED
Clinical Utility of Subcutaneous Furosemide in Patients Presenting With Early Signs of Fluid Overload
Lead Sponsor:
Steward St. Elizabeth's Medical Center of Boston, Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 a...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2019
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03359161
Start Date
April 5 2018
End Date
January 31 2019
Last Update
October 13 2022
Active Locations (1)
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1
St ELizabeth's Medical Center
Brighton, Massachusetts, United States, 02135