Heart FailurePhase 2/3NCT03359161
Clinical Utility of Subcutaneous Furosemide in Patients Presenting With Early Signs of Fluid Overload
A Phase 2/3 study testing sc2Wear Furosemide Infusor in people with Heart Failure, run by Steward St. Elizabeth's Medical Center of Boston, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- sc2Wear Furosemide Infusor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2018to 31 Jan 2019
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
St ELizabeth's Medical Center
Brighton, Massachusetts, 02135
About this study
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
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- sc2Wear Furosemide Infusor
- Keywords
- ambulatory, Subcutaneous, furosemide
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sc2Wear Furosemide InfusorCombination product
Subcutaneous furosemide for the treatment of fluid overload
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: sc2Wear Furosemide Infusor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Change
Weight change between enrollment/screening compared to last observation
Measured: 30 days
Pro BNP Change
Reduction in pro-BNP between enrollment/screening compared to last observation
Measured: 30 days
Survival
% of patients alive 30 days post enrollment
Measured: 30 days
Hospital Admission for Heart Failure
% of patients without hospitalization for worsening HF within 30 days after enrollment
Measured: 30 days
Heart Failure Related Events
% of patients without a significant Heart Failure related medical events within 30 days after enrollment.
Measured: 30 days
Extra Furosemide Treatment
Percentage of patients requiring additional 4 days of diuresis
Measured: 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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start5 Apr 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Why it stopped: Development of first generation device discontinued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lana Tsao, MD, Principal investigator, St. Elizabeth's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359161
- Sponsor's protocol ID
- Clinical Protocol Version 4.0
- Status last verified
- Aug 2021
- First submitted
- 27 Nov 2017
- Last updated
- 13 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03359161
- Acronym / sponsor ID
- Clinical Protocol Version 4.0
- Conditions
- Heart Failure
- Keywords
- ambulatory, Subcutaneous, furosemide
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Development of first generation device discontinued.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.University, hospital or other
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 2 Dec 2017 (actual)
- Results
- Posted 13 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| In-Home Subcutaneous Furosemide Treatment ARm | Experimental | Combination Product: sc2Wear Furosemide InfusorProspective, open-label arm to evaluate the clinical effectiveness of a novel formulation of furosemide delivered by subcutaneous administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sc2Wear Furosemide InfusorSubcutaneous furosemide for the treatment of fluid overload | Combination product | In-Home Subcutaneous Furosemide Treatment ARm |
Primary outcome
Weight Change
Time frame: 30 days
Weight change between enrollment/screening compared to last observation
Pro BNP Change
Time frame: 30 days
Reduction in pro-BNP between enrollment/screening compared to last observation
Survival
Time frame: 30 days
% of patients alive 30 days post enrollment
Hospital Admission for Heart Failure
Time frame: 30 days
% of patients without hospitalization for worsening HF within 30 days after enrollment
Heart Failure Related Events
Time frame: 30 days
% of patients without a significant Heart Failure related medical events within 30 days after enrollment.
Extra Furosemide Treatment
Time frame: 7 days
Percentage of patients requiring additional 4 days of diuresis
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lana Tsao, MD principal investigator
St. Elizabeth's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing sc2Wear Furosemide Infusor in people with Heart Failure, run by Steward St. Elizabeth's Medical Center of Boston, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Change (time frame: 30 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.