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Trial record 4 of 6 for:    Subcutaneous furosemide | Heart Failure | United States

Subcutaneous Furosemide in Acute Decompensated Heart Failure: The SUBQ-HF Study (SUBQ-HF)

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ClinicalTrials.gov Identifier: NCT03170219
Recruitment Status : Terminated (Slow enrollment)
First Posted : May 30, 2017
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Adrian Hernandez, Duke University

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Heart Failure Decompensated Heart Failure Combination Product: subcutaneous furosemide and sc2wear device Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Subcutaneous Furosemide in Acute Decompensated Heart Failure: The SUBQ-HF Study
Actual Study Start Date : April 27, 2018
Actual Primary Completion Date : September 20, 2018
Actual Study Completion Date : September 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Furosemide

Arm Intervention/treatment
Experimental: Subcutaneous Furosemide and sc2wear device
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.
Combination Product: subcutaneous furosemide and sc2wear device
subcutaneous furosemide administered via sc2wear device vs. standard of care

No Intervention: Usual Care
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.



Primary Outcome Measures :
  1. Days alive and out of the hospital between randomization and day 30 [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Composite safety endpoint of death, sustained ventricular arrhythmias, and severe hypokalemia [ Time Frame: 30 days ]
  2. Medical costs from randomization through 30 days [ Time Frame: 30 days ]
  3. Days alive and outside the hospital through 14 days [ Time Frame: 14 days ]
  4. 30 day Heart Failure readmission [ Time Frame: 30 days ]
  5. 30 day ED visit for Heart Failure [ Time Frame: 30 days ]
  6. Death at 30 days [ Time Frame: 30 days ]
  7. Change in breathlessness through day 7 [ Time Frame: 7 days ]
    On a 0-10 scale of breathlessness

  8. Change in renal function using eGFR baseline to 30 days [ Time Frame: 30 days ]
  9. Change in NT pro BNP from baseline to 30 days [ Time Frame: 30 days ]
  10. Patient Safety measured by adverse events [ Time Frame: 30 days ]
    measured by adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Pathway 1 (patients hospitalized with acute heart failure)

  1. Age >18 years
  2. Willingness and ability to provide informed consent
  3. Hospitalization for AHF with at least 1 symptom (dyspnea, orthopnea, or edema) AND 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography, BNP > 250 ng/mL or NTproBNP > 1000 ng/mL) of congestion
  4. Persistent congestion defined by the presence of at least 2 or more of the following at the time of consent:

    1. Peripheral edema
    2. Rales
    3. Elevated JVP
    4. Ascites
    5. BNP > 250 ng/mL or NTproBNP > 1000 ng/mL during index hospitalization
    6. Orthopnea
  5. Total anticipated daily IV furosemide dose (at time of screening) >80-240 mg (or equivalent)/day
  6. Anticipated need for at least 24 more hours of parenteral diuretic therapy

Exclusion Criteria for Pathway 1

  1. Severe renal dysfunction (eGFR< 20 ml/min/1.73m2) within 24 hours of enrollment
  2. Requirement for inotropes (other than digoxin) or mechanical support during hospitalization
  3. Clinically significant electrical instability during hospitalization
  4. Anticipated need for ongoing intravenous therapies beyond diuretics (electrolyte repletion, vasodilators, antibiotics, etc.)
  5. Planned discharge to location other than home (e.g., hospice, skilled nursing facility, etc.)
  6. Anticipated cardiac transplantation or left ventricular assist device within the next 30 days
  7. Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, acute myocarditis, constrictive pericarditis or tamponade
  8. Known or anticipated pregnancy in the next 30 days
  9. 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.
  10. Other psychosocial or physical barriers to following the protocol and using SQ pump device outside the hospital setting
  11. Known allergy to furosemide
  12. Known sensitivity or allergy to medical adhesive tape
  13. Enrollment or planned enrollment in another therapeutic clinical trial in next 3 months
  14. 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)

  1. Age >18 years
  2. Willingness and ability to provide informed consent
  3. HF now presenting with volume overload defined by the presence of at least 2 or more of the following at the time of consent:

    1. Peripheral edema
    2. Rales
    3. Elevated JVP
    4. Ascites
    5. BNP > 250 ng/mL or NTproBNP > 1000 ng/mL during this episode of decompensation
    6. Orthopnea
  4. Need for parenteral furosemide with an estimated SQ furosemide requirement between 80-240 mg/day
  5. Anticipated need for at least 24 hours of parenteral diuretic therapy

Exclusion Criteria for Pathway 2

  1. Severe renal dysfunction (eGFR< 20 ml/min/1.73m2) within 24 hours of enrollment
  2. Anticipated need for inotropes (other than digoxin) or mechanical support to treat current episode of decompensation
  3. Clinically significant electrical instability requiring hospitalization
  4. Anticipated need for ongoing intravenous therapies beyond diuretics (electrolyte repletion, vasodilators, antibiotics, etc.)
  5. Residence at location other than home (e.g., hospice, skilled nursing facility, etc.)
  6. Anticipated cardiac transplantation or left ventricular assist device within the next 30 days
  7. Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, acute myocarditis, constrictive pericarditis or tamponade
  8. Known or anticipated pregnancy in the next 30 days
  9. 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.
  10. Other psychosocial or physical barriers to following the protocol and using SQ pump device outside the hospital setting
  11. Known allergy to furosemide
  12. Known sensitivity or allergy to medical adhesive tape
  13. Enrollment or planned enrollment in another therapeutic clinical trial in next 3 months.
  14. Presentation is for indication other than CHF.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170219


Locations
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
Saint Louis University Hospital
Saint Louis, Missouri, United States, 63117
United States, New York
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
United States, Ohio
University Hospitals- Case Medical Center
Cleveland, Ohio, United States, 44106
Metro Health System
Cleveland, Ohio, United States, 44109
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvaina
Philadelphia, Pennsylvania, United States, 19104
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
Adrian Hernandez
Investigators
Principal Investigator: Adrian Hernandez, MD Duke University
Study Chair: Eugene Braunwald, MD Harvard University

Responsible Party: Adrian Hernandez, HFN Coordinating Center PI, Duke University
ClinicalTrials.gov Identifier: NCT03170219     History of Changes
Other Study ID Numbers: Pro00070619
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Furosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action