Acute Heart FailurePhase 2SUBQ-HFNCT03170219
Subcutaneous Furosemide in Acute Decompensated Heart Failure: The SUBQ-HF Study
A Phase 2 study testing subcutaneous furosemide and sc2wear device in people with Acute Heart Failure and Decompensated Heart Failure, run by Adrian Hernandez at 16 sites in United States.
Trial summary
To determine if a strategy of early discharge using a novel subcutaneous delivery system for parenteral furosemide can improve clinical outcomes within 30 days of randomization (days alive and outside the hospital) compared to usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure, Decompensated Heart Failure
- What is being tested?
- subcutaneous furosemide and sc2wear device
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 16 sitesUnited States
- Study dates
- 27 Apr 2018to 20 Sep 2018
- 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
None listed.
Who cannot join
- Severe renal dysfunction (eGFR< 20 ml/min/1.73m2) within 24 hours of enrollment
- Requirement for inotropes (other than digoxin) or mechanical support during hospitalization
- Clinically significant electrical instability during hospitalization
- Anticipated need for ongoing intravenous therapies beyond diuretics (electrolyte repletion, vasodilators, antibiotics, etc.)
- Planned discharge to location other than home (e.g., hospice, skilled nursing facility, etc.)
- Anticipated cardiac transplantation or left ventricular assist device within the next 30 days
Show all 40Show fewer
- Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, acute myocarditis, constrictive pericarditis or tamponade
- Known or anticipated pregnancy in the next 30 days
- Prior use of a subcutaneous furosemide pump or current use of any subcutaneous pump, on-body infusion devices or patients who give regimented injections at the intended site of the furosemide infusion device.
- Other psychosocial or physical barriers to following the protocol and using SQ pump device outside the hospital setting
- Known allergy to furosemide
- Known sensitivity or allergy to medical adhesive tape
- Enrollment or planned enrollment in another therapeutic clinical trial in next 3 months
- Presentation is for indication other than CHF
- Inclusion Criteria for Pathway 2 (Outpatients with heart failure presenting with volume overload necessitating treatment with parenteral loop diuretics)
- Age >18 years
- Willingness and ability to provide informed consent
- HF now presenting with volume overload defined by the presence of at least 2 or more of the following at the time of consent:
- Peripheral edema
- Rales
- Elevated JVP
- Ascites
- BNP > 250 ng/mL or NTproBNP > 1000 ng/mL during this episode of decompensation
- Orthopnea
- Need for parenteral furosemide with an estimated SQ furosemide requirement between 80-240 mg/day
- Anticipated need for at least 24 hours of parenteral diuretic therapy
- Severe renal dysfunction (eGFR< 20 ml/min/1.73m2) within 24 hours of enrollment
- Anticipated need for inotropes (other than digoxin) or mechanical support to treat current episode of decompensation
- Clinically significant electrical instability requiring hospitalization
- Anticipated need for ongoing intravenous therapies beyond diuretics (electrolyte repletion, vasodilators, antibiotics, etc.)
- Residence at location other than home (e.g., hospice, skilled nursing facility, etc.)
- Anticipated cardiac transplantation or left ventricular assist device within the next 30 days
- Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, acute myocarditis, constrictive pericarditis or tamponade
- Known or anticipated pregnancy in the next 30 days
- Prior use of a subcutaneous furosemide pump or current use of any subcutaneous pump, on-body infusion devices or patients who give regimented injections at the intended site of the furosemide infusion device.
- Other psychosocial or physical barriers to following the protocol and using SQ pump device outside the hospital setting
- Known allergy to furosemide
- Known sensitivity or allergy to medical adhesive tape
- Enrollment or planned enrollment in another therapeutic clinical trial in next 3 months.
- Presentation is for indication other than CHF.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Emory University Hospital
Atlanta, Georgia, 30322
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Vermont
Burlington, Vermont, 05401
Northwestern University
Chicago, Illinois, 60611
University Hospitals- Case Medical Center
Cleveland, Ohio, 44106
Metro Health System
Cleveland, Ohio, 44109
Cleveland Clinic
Cleveland, Ohio, 44195
Duke University
Durham, North Carolina, 27705
University of Pennsylvaina
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
Washington University
St Louis, Missouri, 63110
Saint Louis University Hospital
St Louis, Missouri, 63117
Stony Brook University Medical Center
Stony Brook, New York, 11794
About this study
To determine if a strategy of early discharge using a novel subcutaneous delivery system for parenteral furosemide can improve clinical outcomes within 30 days of randomization (days alive and outside the hospital) compared to usual care.
Read the detailed description
SUBQ-HF is a multicenter clinical trial of selected AHF patients with persistent congestion. This study will evaluate a strategy of early discharge (pathway 1) or admission avoidance (pathway 2) with daily SQ furosemide compared to usual care in a population who have objective evidence of persistent congestion requiring ongoing parenteral diuretics. This will be an unblinded, randomized, controlled study of approximately 300 evaluable patients. Eligible patients will be randomized (1:1) to either:
Usual care strategy, during which patients will have continued inpatient treatment and discharge follow-up as per usual standard of care plus a Day 7 phone call and Day 30 study visit.
or
Subcutaneous strategy, in which patients will be discharged home within 24 hours of randomization (pathway 1) or sent home from clinic or ED to receive furosemide with the SQ pump for 1-7 days (based on clinical response) plus a Day 7 and Day 30 visit.
Subcutaneous furosemide/early discharge strategy:
Subjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Training will include instruction on daily weights and dyspnea numerical rating for symptoms. Scales will be provided to subjects. Subjects will be discharged with planned treatment of 80 mg SQ furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements. If there are unanticipated delays in discharge after randomization, subjects will continue with their assigned therapy and assessments in the hospital. Discharged subjects will receive a phone contact from study team on D1, D3, and D5 in order to assess adequacy of diuresis, persistence of congestion, and planned duration, dose of ongoing SQ therapy (see Appendix for guidelines on adjusting therapy) and adverse events. Additional clinical contact (additional phone contacts or clinical visits) may be performed if felt clinically indicated by the study team or clinical provider. All subjects will have assessment of electrolytes and renal function by protocol 2 days post discharge. More frequent electrolyte monitoring can be performed at the discretion of the study team or clinical provider as clinically indicated. Patients receiving the SQ pump for outpatient use should be prescribed a supplementation regimen based on electrolyte supplementation needs in the hospital with IV diuretic therapy. The duration of subcutaneous therapy will be planned for 1-7 days depending on clinical response. Dose and frequency of oral diuretics once SQ therapy is completed will be per the discretion of the treating physician.
Usual care strategy:
Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines. In addition, they will have a Day 7 study phone call and a Day 30 study visit.
- Conditions
- Acute Heart Failure, Decompensated Heart Failure
- Being tested
- subcutaneous furosemide and sc2wear device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subcutaneous furosemide and sc2wear deviceCombination product
subcutaneous furosemide administered via sc2wear device vs. standard of care
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous Furosemide and sc2wear device | Experimental | Subjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Subjects will be discharged with planned treatment of 80 mg subcutaneous furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements. Receives: Combination Product: subcutaneous furosemide and sc2wear device |
| Usual Care | No intervention | Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Safety Measured by Serious Adverse Events
measured by serious adverse events
Measured: 30 days
Secondary outcomes (9)
Composite Safety Endpoint of Death, Sustained Ventricular Arrhythmias, and Severe Hypokalemia
Measured: 30 days
Medical Costs From Randomization Through 30 Days
Measured: 30 days
Days Alive and Outside the Hospital Through 14 Days
Measured: 14 days
30 Day Heart Failure Readmission
Measured: 30 days
30 Day ED Visit for Heart Failure
Measured: 30 days
Death at 30 Days
Measured: 30 days
Change in Breathlessness Through Day 7
On a 0-10 scale of breathlessness
Measured: 7 days
Change in Renal Function Using eGFR Baseline to 30 Days
Measured: 30 days
Change in NT Pro BNP From Baseline to 30 Days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start27 Apr 2018
- Primary completion20 Sep 2018
- Study completion20 Sep 2018
Why it stopped: Slow enrollment
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 Acute 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adrian Hernandez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adrian Hernandez, Duke University
- Investigators
- Adrian Hernandez, MD, Principal investigator, Duke UniversityEugene Braunwald, MD, Study chair, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170219
- Sponsor's protocol ID
- Pro00070619
- Acronym
- SUBQ-HF
- Status last verified
- Jan 2019
- First submitted
- 6 May 2017
- Last updated
- 23 Jan 2019
- 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 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Furosemide in Acute Decompensated Heart Failure: The SUBQ-HF Study
- ClinicalTrials.gov ID
- NCT03170219
- Acronym / sponsor ID
- SUBQ-HF / Pro00070619
- Conditions
- Acute Heart Failure, Decompensated Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Adrian HernandezUniversity, hospital or other
- Study start
- 27 Apr 2018 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 20 Sep 2018 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Posted 23 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if a strategy of early discharge using a novel subcutaneous delivery system for parenteral furosemide can improve clinical outcomes within 30 days of randomization (days alive and outside the hospital) compared to usual care.
Detailed description
SUBQ-HF is a multicenter clinical trial of selected AHF patients with persistent congestion. This study will evaluate a strategy of early discharge (pathway 1) or admission avoidance (pathway 2) with daily SQ furosemide compared to usual care in a population who have objective evidence of persistent congestion requiring ongoing parenteral diuretics. This will be an unblinded, randomized, controlled study of approximately 300 evaluable patients. Eligible patients will be randomized (1:1) to either:
Usual care strategy, during which patients will have continued inpatient treatment and discharge follow-up as per usual standard of care plus a Day 7 phone call and Day 30 study visit.
or
Subcutaneous strategy, in which patients will be discharged home within 24 hours of randomization (pathway 1) or sent home from clinic or ED to receive furosemide with the SQ pump for 1-7 days (based on clinical response) plus a Day 7 and Day 30 visit.
Subcutaneous furosemide/early discharge strategy:
Subjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Training will include instruction on daily weights and dyspnea numerical rating for symptoms. Scales will be provided to subjects. Subjects will be discharged with planned treatment of 80 mg SQ furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements. If there are unanticipated delays in discharge after randomization, subjects will continue with their assigned therapy and assessments in the hospital. Discharged subjects will receive a phone contact from study team on D1, D3, and D5 in order to assess adequacy of diuresis, persistence of congestion, and planned duration, dose of ongoing SQ therapy (see Appendix for guidelines on adjusting therapy) and adverse events. Additional clinical contact (additional phone contacts or clinical visits) may be performed if felt clinically indicated by the study team or clinical provider. All subjects will have assessment of electrolytes and renal function by protocol 2 days post discharge. More frequent electrolyte monitoring can be performed at the discretion of the study team or clinical provider as clinically indicated. Patients receiving the SQ pump for outpatient use should be prescribed a supplementation regimen based on electrolyte supplementation needs in the hospital with IV diuretic therapy. The duration of subcutaneous therapy will be planned for 1-7 days depending on clinical response. Dose and frequency of oral diuretics once SQ therapy is completed will be per the discretion of the treating physician.
Usual care strategy:
Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines. In addition, they will have a Day 7 study phone call and a Day 30 study visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous Furosemide and sc2wear device | Experimental | Combination Product: subcutaneous furosemide and sc2wear deviceSubjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Subjects will be discharged with planned treatment of 80 mg subcutaneous furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements. |
| Usual Care | No intervention | –Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (40 listed)
- Severe renal dysfunction (eGFR< 20 ml/min/1.73m2) within 24 hours of enrollment
- Requirement for inotropes (other than digoxin) or mechanical support during hospitalization
- Clinically significant electrical instability during hospitalization
- Anticipated need for ongoing intravenous therapies beyond diuretics (electrolyte repletion, vasodilators, antibiotics, etc.)
- Planned discharge to location other than home (e.g., hospice, skilled nursing facility, etc.)
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 |
|---|---|---|
| subcutaneous furosemide and sc2wear devicesubcutaneous furosemide administered via sc2wear device vs. standard of care | Combination product | Subcutaneous Furosemide and sc2wear device |
Primary outcome
Patient Safety Measured by Serious Adverse Events
Time frame: 30 days
measured by serious adverse events
9 secondary outcomes
Composite Safety Endpoint of Death, Sustained Ventricular Arrhythmias, and Severe Hypokalemia
Time frame: 30 days
Medical Costs From Randomization Through 30 Days
Time frame: 30 days
Days Alive and Outside the Hospital Through 14 Days
Time frame: 14 days
30 Day Heart Failure Readmission
Time frame: 30 days
30 Day ED Visit for Heart Failure
Time frame: 30 days
Death at 30 Days
Time frame: 30 days
Change in Breathlessness Through Day 7
Time frame: 7 days
Change in Renal Function Using eGFR Baseline to 30 Days
Time frame: 30 days
Change in NT Pro BNP From Baseline to 30 Days
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Acute Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Not yet recruitingPhase 3
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
Heart Failure, Acute Decompensated Heart Failure
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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.
Adrian Hernandez, MD principal investigator
Duke University
Eugene Braunwald, MD study chair
Harvard University
16 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 subcutaneous furosemide and sc2wear device in people with Acute Heart Failure and Decompensated Heart Failure, run by Adrian Hernandez at 16 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 0 inclusion and 40 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 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 23 Jan 2019). 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?
Patient Safety Measured by Serious Adverse Events (time frame: 30 days). 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 23 Jan 2019.