Heart FailurePhase 2AT HOME-HFNCT04593823
Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failure - A Pilot Study
A Phase 2 study testing Furoscix Infusor in people with Heart Failure, run by scPharmaceuticals, Inc. at 18 sites in United States.
Trial summary
This is a multicenter, randomized, open label, controlled study evaluating the effectiveness, and safety of the Furoscix Infusor vs continued medical therapy in patients with chronic heart failure and fluid overload requiring augmentation in diuretic therapy outside of acute care setting. 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?
- Furoscix Infusor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 18 sitesUnited States
- Study dates
- 3 May 2021to 18 Apr 2022
- Phase
- Phase 2
- 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
- Subjects are eligible for inclusion only if all the following criteria are met:
- Age 18 years or older.
- Diagnosis of symptomatic chronic heart failure (NYHA Class II-IV) with background loop diuretic therapy for at least 4 weeks.
- Need for augmented diuresis outside of the acute care setting as determined by the investigator.
- On background therapy including daily total furosemide equivalent dose (40-160 mg) of loop diuretic or equivalent.
- The subject must have signs of volume expansion, defined as two or more of the following six signs:
Show all 17Show fewer
- jugular venous distention
- edema (≥ 1+)
- ascites
- pulmonary congestion on chest x-ray
- pulmonary rales
- NT-proBNP ≥1000 pg/ml (1400 for patients in atrial fibrillation) or, for patients not on Entresto, BNP ≥200 (400 for patients in atrial fibrillation)
- Increase over the preceding 30 days in at least one of the following symptoms characteristic of worsening heart failure:
- dyspnea
- fatigue
- exercise intolerance
- Adequate environment for at home administration of Furoscix by patient or caregiver.
Who cannot join
- A Subject is not eligible for inclusion if any of the following criteria apply:
- Suspected high risk clinical instability with outpatient treatment.
- Presence of a complicating condition, other than heart failure likely to require hospitalization in next 30 days.
- Pregnant women or women of childbearing age who are not willing to use an adequate form of contraception.
- Known allergy to the active and inactive ingredients of the study medication or device adhesive.
- On experimental medication or currently participating in another interventional research study.
Show all 11Show fewer
- eGFR < 20
- Serum potassium at baseline > 5.4 or < 3.6
- Concomitant infection
- Heart rate > 110
- Received IV furosemide or bumetanide within last 24 hours
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
University Hospital - Augusta
Augusta, Georgia, 30901
Aventura Clinical Research, LLC
Aventura, Florida, 33541
Advocate Health and Hospitals
Downers Grove, Illinois, 60515
Heart Group of Eastern Shore
Fairhope, Alabama, 36532
University of Florida
Gainesville, Florida, 32611
Cone Health Medical Group
Greensboro, North Carolina, 27455
Hartford Hospital
Hartford, Connecticut, 06102
Elite Cardiac Research
Hialeah, Florida, 33012
The Heart Center Research, LLC
Huntsville, Alabama, 35801
First Coast Cardiovascular Institute
Jacksonville, Florida, 32256
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
University of Wisconsin
Madison, Wisconsin, 53792
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Cardiology Consultants
Pensacola, Florida, 32501
UnityPoint Health - Methodist Hospital
Peoria, Illinois, 61606
St. Louis Heart and Vascular
St Louis, Missouri, 63136
James A. Haley Veerans Hospital
Tampa, Florida, 33612
Michigan Heart
Ypsilanti, Michigan, 48197
About this study
Official title: A Multicenter, Randomized, Open Label, Controlled Study Evaluating the Effectiveness and Safety of Furoscix On-Body Infusor vs Continued Medical Therapy for Worsening Heart Failure
This is a multicenter, randomized, open label, controlled study evaluating the effectiveness, and safety of the Furoscix Infusor vs continued medical therapy in patients with chronic heart failure and fluid overload requiring augmentation in diuretic therapy outside of acute care setting.
The study drug, Furoscix (furosemide injection 8 mg/ml), is a furosemide solution buffered to a neutral pH containing 80 mg/10 mL for subcutaneous administration over 5 hours via the Furoscix Infusor.
Read more
The study objectives are:
- To provide pilot data on the effectiveness and safety to inform a pivotal trial.
- To inform population enrichment strategies
- To refine pivotal trial endpoints and analytical methods
- To identify operational challenges of study design
- To assess patient adherence, competence, and experience
- To familiarize staff and patients with device application and use
Read the detailed description
The purpose of this study is to evaluate the effectiveness and safety of the Furoscix Infusor vs continued medical therapy in patients with chronic heart failure and fluid overload requiring augmentation in diuretic therapy outside of acute care setting. 51 patients will be randomly assigned (2:1) to receive Furoscix vs continued medical therapy.
The Treatment Phase comprises a pre-programmed bi-phasic 5-hour drug administration of Furoscix (80 mg/10 mL) via the On-body Infusor. Subjects and/or their caregivers will be trained on device preparation, placement and removal in accordance with product instructions of use (IFU). Subjects should be transitioned back to their oral maintenance diuretic regimen when clinically indicated at the discretion of the investigator.
Over the initial 7 days, all subjects will receive daily clinic or phone follow-up by the study staff. Decision of treatment with Furoscix in the intervention arm as well as changes in oral diuretic dosing in the control arm will be determined by the treating physician in coordination with the study nurse. Safety labs will be done on Days 1, 3, 7 and 30.
After Subjects have been transitioned to their oral maintenance diuretic regimen, additional doses of Furoscix (for Furoscix group) or IV diuretics (for Treat as Usual group) can be prescribed during the 30-day study period as needed based on the presence of congestion symptoms (e.g. dyspnea, edema, and/or excess weight gain) as determined by the investigator.
The Follow-Up Phase will include a visit to the clinic on Day 30 +/- 5 days where effectiveness and safety assessments will be performed including limited physical exam (including NYHA Class), Composite Congestion Score (CCS), 5-point Current Dyspnea Score, 7-point Dyspnea Score, vital signs, laboratory analyses, KCCQ-12, Visual Analog Score (VAS), 6MWT and adverse events.
- Conditions
- Heart Failure
- Being tested
- Furoscix Infusor
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furoscix InfusorCombination product
Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours.
| Study group | Role | What they receive |
|---|---|---|
| Furoscix Infusor | Experimental | Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours). Receives: Combination Product: Furoscix Infusor |
| Continued Medical Therapy | No intervention | The subjects enrolled in this arm will receive treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Win Ratio of Composite Endpoint
Win Ratio calculated as number of pairs of Furoscix On-Body Infusor subject "wins" divided by number of pairs of Furoscix On-Body Infusor subject "losses" when compared to Continued Medical Therapy subjects.
Components of Endpoint composite outcome: CV death, HF hospitalization, Urgent ED/Clinic visit at 30 days and percent change in NT-proBNP from baseline at Day 7.
See Statistical Analysis Plan for detailed explanation of this statistical method.
Measured: Day 7, Day 30
Number of Cardiovascular Deaths
Total number of CV deaths between two groups
Measured: Baseline, 30 Days
Number of Heart Failure Hospitalizations
Heart Failure hospitalizations compared between two groups
Measured: 30 Days
Number of Urgent ED/Clinic Visits for Worsening Heart Failure
Urgent ED/Clinic visits for worsening heart failure compared between two groups.
Statistical analysis was not performed due to no ED/Clinic visits
Measured: 30 Days
NT-proBNP Change From Baseline
Percentage change in NT-proBNP from baseline at Day 7 compared between two groups
Measured: 30 Days
Secondary outcomes (11)
Number of Heart Failure Event Free Survival Days
Out of 30 days, HF event-free survival is the average number of days subjects survived outside the hospital event-free.
Measured: 30 Days
Number of Subjects Deceased or HF Event Occurred
Subjects that are Deceased or HF event occurred (hospitalization for HF or urgent ED/clinic visits for HF) over 30 days compared between treatment groups.
Measured: 30 Days
Visual Analog Scale (VAS)
The patient global assessment VAS is a patient-reported assessment of how good or bad a patient feels their health is on a given day. It is reported on a visual scale of 0 to 100, with 0 being the worst health they can imagine and 100 being the best health they can imagine.
Measured: Baseline, 7 Days, 30 Days
Composite Congestion Score (CCS)
The composite congestion score (ccs) is calculated by summing the individual scores for orthopnea, pedal edema and jugular venous distension.
The investigator-assessed the signs and symptoms of congestion (orthopnea, pedal edema, and jugular venous distension) on a 4-point grading scale ranging from 0 to 3.
Higher score indicates greater severity of symptoms ranging from 0 to 9.
Measured: Baseline, Day 7, Day 30
5-Point Current Dyspnea Score
The 5-Point Current Dyspnea Status Questionnaire is a single-item, self-administered instrument that quantifies current symptoms of dyspnea. The scale includes the absence of dyspnea (a score of 1), mild shortness of breath (a score of 2), moderate shortness of breath (a score of 3), severe shortness of breath (a score of 4) and the worst possible shortness of breath (a score of 5)
Measured: Baseline, Day 7, Day 30
7-Point Dyspnea Score
The 7-Point Dyspnea Status Questionnaire is a single-item, self-administered instrument that quantifies changes in dyspnea symptoms since initiation of study product. The scale ranges from Markedly better, Moderately better, Minimaly better, No change, Minimally worse, Moderately worse to Markedly worse.
Measured: Baseline, Day 3, Day 7, Day 30
KCCQ-12 Summary Score
The KCCQ-12 questionnaire is a patient-reported assessment to capture symptom frequency, physical and social limitations, and quality-of-life impairment as a result of HF, as well as an overall summary score. In the KCCQ-12, responses are given for each individual item is scored on a scale of 0-100 with higher scores indicating better health.
Measured: Baseline, 7 Days, 30 Days
Six-Minute Walk Test (6MWT)
Change from baseline in Six-Minute Walk Test (6MWT) across follow-up timepoints
Measured: Baseline, 7 Days, 30 Days
Percent Lung Fluid
Lung fluid volume as measured via Remote Dielectric Sensing (ReDS)
Measured: Baseline, Day 7, Day 30
Body Weight
Body weight of the patient on the day of visit
Measured: Baseline, Day 3, Day 7, Day 30
Renal Function
Change from baseline in serum creatinine
Measured: Baseline, Day 3, Day 7, Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start3 May 2021
- Primary completion18 Apr 2022
- Study completion18 Apr 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- scPharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marvin A Konstam, MD, Principal investigator, Principal InvestigatorJames E Udelson, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593823
- Sponsor's protocol ID
- scP-01-008
- Acronym
- AT HOME-HF
- Status last verified
- Jul 2023
- First submitted
- 2 Oct 2020
- Last updated
- 1 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Konstam MA, Massaro J, Dhingra R, Walsh M, Ordway L, Pursley MS, McLean DS, Saha S, Close N, Konstam JM, Luepke KH, Mohr JF, Udelson JE. Avoiding Treatment in Hospital With Subcutaneous Furosemide for Worsening Heart Failure: A Pilot Study (AT HOME-HF). JACC Heart Fail. 2024 Nov;12(11):1830-1841. doi: 10.1016/j.jchf.2024.07.015. Epub 2024 Sep 11.
PubMed 39269392
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open Label, Controlled Study Evaluating the Effectiveness and Safety of Furoscix On-Body Infusor vs Continued Medical Therapy for Worsening Heart Failure
- ClinicalTrials.gov ID
- NCT04593823
- Acronym / sponsor ID
- AT HOME-HF / scP-01-008
- Conditions
- Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- scPharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 May 2021 (actual)
- Primary completion
- 18 Apr 2022 (actual)
- Study completion
- 18 Apr 2022 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Posted 1 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, open label, controlled study evaluating the effectiveness, and safety of the Furoscix Infusor vs continued medical therapy in patients with chronic heart failure and fluid overload requiring augmentation in diuretic therapy outside of acute care setting.
The study drug, Furoscix (furosemide injection 8 mg/ml), is a furosemide solution buffered to a neutral pH containing 80 mg/10 mL for subcutaneous administration over 5 hours via the Furoscix Infusor.
The study objectives are:
- To provide pilot data on the effectiveness and safety to inform a pivotal trial.
- To inform population enrichment strategies
- To refine pivotal trial endpoints and analytical methods
- To identify operational challenges of study design
- To assess patient adherence, competence, and experience
- To familiarize staff and patients with device application and use
Detailed description
The purpose of this study is to evaluate the effectiveness and safety of the Furoscix Infusor vs continued medical therapy in patients with chronic heart failure and fluid overload requiring augmentation in diuretic therapy outside of acute care setting. 51 patients will be randomly assigned (2:1) to receive Furoscix vs continued medical therapy.
The Treatment Phase comprises a pre-programmed bi-phasic 5-hour drug administration of Furoscix (80 mg/10 mL) via the On-body Infusor. Subjects and/or their caregivers will be trained on device preparation, placement and removal in accordance with product instructions of use (IFU). Subjects should be transitioned back to their oral maintenance diuretic regimen when clinically indicated at the discretion of the investigator.
Over the initial 7 days, all subjects will receive daily clinic or phone follow-up by the study staff. Decision of treatment with Furoscix in the intervention arm as well as changes in oral diuretic dosing in the control arm will be determined by the treating physician in coordination with the study nurse. Safety labs will be done on Days 1, 3, 7 and 30.
After Subjects have been transitioned to their oral maintenance diuretic regimen, additional doses of Furoscix (for Furoscix group) or IV diuretics (for Treat as Usual group) can be prescribed during the 30-day study period as needed based on the presence of congestion symptoms (e.g. dyspnea, edema, and/or excess weight gain) as determined by the investigator.
The Follow-Up Phase will include a visit to the clinic on Day 30 +/- 5 days where effectiveness and safety assessments will be performed including limited physical exam (including NYHA Class), Composite Congestion Score (CCS), 5-point Current Dyspnea Score, 7-point Dyspnea Score, vital signs, laboratory analyses, KCCQ-12, Visual Analog Score (VAS), 6MWT and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Furoscix Infusor | Experimental | Combination Product: Furoscix InfusorFuroscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours). |
| Continued Medical Therapy | No intervention | –The subjects enrolled in this arm will receive treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age 18 years or older.
- Diagnosis of symptomatic chronic heart failure (NYHA Class II-IV) with background loop diuretic therapy for at least 4 weeks.
- Need for augmented diuresis outside of the acute care setting as determined by the investigator.
- On background therapy including daily total furosemide equivalent dose (40-160 mg) of loop diuretic or equivalent.
- The subject must have signs of volume expansion, defined as two or more of the following six signs:
Key exclusion criteria (11 listed)
- Suspected high risk clinical instability with outpatient treatment.
- Presence of a complicating condition, other than heart failure likely to require hospitalization in next 30 days.
- Pregnant women or women of childbearing age who are not willing to use an adequate form of contraception.
- Known allergy to the active and inactive ingredients of the study medication or device adhesive.
- On experimental medication or currently participating in another interventional research study.
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 |
|---|---|---|
| Furoscix InfusorFuroscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours. | Combination product | Furoscix Infusor |
Primary outcome
Win Ratio of Composite Endpoint
Time frame: Day 7, Day 30
Win Ratio calculated as number of pairs of Furoscix On-Body Infusor subject "wins" divided by number of pairs of Furoscix On-Body Infusor subject "losses" when compared to Continued Medical Therapy subjects. Components of Endpoint composite outcome: CV death, HF hospitalization, Urgent ED/Clinic visit at 30 days and percent change in NT-proBNP from baseline at Day 7. See Statistical Analysis Plan for detailed explanation of this statistical method.
Number of Cardiovascular Deaths
Time frame: Baseline, 30 Days
Total number of CV deaths between two groups
Number of Heart Failure Hospitalizations
Time frame: 30 Days
Heart Failure hospitalizations compared between two groups
Number of Urgent ED/Clinic Visits for Worsening Heart Failure
Time frame: 30 Days
Urgent ED/Clinic visits for worsening heart failure compared between two groups. Statistical analysis was not performed due to no ED/Clinic visits
NT-proBNP Change From Baseline
Time frame: 30 Days
Percentage change in NT-proBNP from baseline at Day 7 compared between two groups
11 secondary outcomes
Number of Heart Failure Event Free Survival Days
Time frame: 30 Days
Number of Subjects Deceased or HF Event Occurred
Time frame: 30 Days
Visual Analog Scale (VAS)
Time frame: Baseline, 7 Days, 30 Days
Composite Congestion Score (CCS)
Time frame: Baseline, Day 7, Day 30
5-Point Current Dyspnea Score
Time frame: Baseline, Day 7, Day 30
7-Point Dyspnea Score
Time frame: Baseline, Day 3, Day 7, Day 30
KCCQ-12 Summary Score
Time frame: Baseline, 7 Days, 30 Days
Six-Minute Walk Test (6MWT)
Time frame: Baseline, 7 Days, 30 Days
Percent Lung Fluid
Time frame: Baseline, Day 7, Day 30
Body Weight
Time frame: Baseline, Day 3, Day 7, Day 30
Renal Function
Time frame: Baseline, Day 3, Day 7, Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39269392Konstam MA, Massaro J, Dhingra R, Walsh M, Ordway L, Pursley MS, McLean DS, Saha S, Close N, Konstam JM, Luepke KH, Mohr JF, Udelson JE. Avoiding Treatment in Hospital With Subcutaneous Furosemide for Worsening Heart Failure: A Pilot Study (AT HOME-HF). JACC Heart Fail. 2024 Nov;12(11):1830-1841. doi: 10.1016/j.jchf.2024.07.015. Epub 2024 Sep 11.
- 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.
Marvin A Konstam, MD principal investigator
Principal Investigator
James E Udelson, MD principal investigator
Principal Investigator
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Furoscix Infusor in people with Heart Failure, run by scPharmaceuticals, Inc. at 18 sites 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 17 inclusion and 11 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: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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 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.
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 1 Aug 2023). 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?
Win Ratio of Composite Endpoint (time frame: Day 7, Day 30). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04593823, which also lists 1 linked publication.
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 1 Aug 2023.