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

NCT03359161 | Terminated Phase 2 Results DMC FDA Drug FDA Device

• 1 other identifier: Clinical Protocol Version 4.0
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Heart Failure

Keywords

ambulatory; Subcutaneous; furosemide

Outcome Measures

Primary Outcomes (7)

• Weight Change

  Weight change between enrollment/screening compared to last observation

  30 days

• Pro BNP Change

  Reduction in pro-BNP between enrollment/screening compared to last observation

  30 days

• Survival

  % of patients alive 30 days post enrollment

  30 days

• Hospital Admission for Heart Failure

  % of patients without hospitalization for worsening HF within 30 days after enrollment

  30 days

• Heart Failure Related Events

  % of patients without a significant Heart Failure related medical events within 30 days after enrollment.

  30 days

• Extra Furosemide Treatment

  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

  The number of participants that discontinued study participation due to the presence of a skin reaction to the drug or device/adhesive.

  7 days

Study Arms (1)

In-Home Subcutaneous Furosemide Treatment ARm

EXPERIMENTAL

Prospective, open-label arm to evaluate the clinical effectiveness of a novel formulation of furosemide delivered by subcutaneous administration.

Combination Product: sc2Wear Furosemide Infusor

Interventions

sc2Wear Furosemide Infusor COMBINATION_PRODUCT

Subcutaneous furosemide for the treatment of fluid overload

In-Home Subcutaneous Furosemide Treatment ARm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

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

Study Sites (1)

St ELizabeth's Medical Center

Brighton, Massachusetts, 02135, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Lana Tsao
• Organization: St. Elizabeth's Medical Center

lana.tsao@steward.org

617-789-3036

Study Officials

• Lana Tsao, MD

  St. Elizabeth's Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 2, 2017
• Study Start: April 5, 2018
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: October 13, 2022
• Results First Posted: October 13, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)