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

Primary Purpose

Acute Heart Failure, Decompensated Heart Failure

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
subcutaneous furosemide and sc2wear device
Sponsored by
Adrian Hernandez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Emory University Hospital
  • Northwestern University
  • Johns Hopkins Hospital
  • Tufts Medical Center
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Mayo Clinic
  • Washington University
  • Saint Louis University Hospital
  • Stony Brook University Medical Center
  • Duke University
  • University Hospitals- Case Medical Center
  • Metro Health System
  • Cleveland Clinic
  • University of Pennsylvaina
  • University of Vermont

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Subcutaneous Furosemide and sc2wear device

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Patient Safety Measured by Serious Adverse Events
measured by serious adverse events

Secondary Outcome Measures

Composite Safety Endpoint of Death, Sustained Ventricular Arrhythmias, and Severe Hypokalemia
Medical Costs From Randomization Through 30 Days
Days Alive and Outside the Hospital Through 14 Days
30 Day Heart Failure Readmission
30 Day ED Visit for Heart Failure
Death at 30 Days
Change in Breathlessness Through Day 7
On a 0-10 scale of breathlessness
Change in Renal Function Using eGFR Baseline to 30 Days
Change in NT Pro BNP From Baseline to 30 Days

Full Information

First Posted
May 6, 2017
Last Updated
January 1, 2019
Sponsor
Adrian Hernandez
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1. Study Identification

Unique Protocol Identification Number
NCT03170219
Brief Title
Subcutaneous Furosemide in Acute Decompensated Heart Failure: The SUBQ-HF Study
Acronym
SUBQ-HF
Official Title
Subcutaneous Furosemide in Acute Decompensated Heart Failure: The SUBQ-HF Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
April 27, 2018 (Actual)
Primary Completion Date
September 20, 2018 (Actual)
Study Completion Date
September 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Adrian Hernandez

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure, Decompensated Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subcutaneous Furosemide and sc2wear device
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
subcutaneous furosemide and sc2wear device
Intervention Description
subcutaneous furosemide administered via sc2wear device vs. standard of care
Primary Outcome Measure Information:
Title
Patient Safety Measured by Serious Adverse Events
Description
measured by serious adverse events
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Composite Safety Endpoint of Death, Sustained Ventricular Arrhythmias, and Severe Hypokalemia
Time Frame
30 days
Title
Medical Costs From Randomization Through 30 Days
Time Frame
30 days
Title
Days Alive and Outside the Hospital Through 14 Days
Time Frame
14 days
Title
30 Day Heart Failure Readmission
Time Frame
30 days
Title
30 Day ED Visit for Heart Failure
Time Frame
30 days
Title
Death at 30 Days
Time Frame
30 days
Title
Change in Breathlessness Through Day 7
Description
On a 0-10 scale of breathlessness
Time Frame
7 days
Title
Change in Renal Function Using eGFR Baseline to 30 Days
Time Frame
30 days
Title
Change in NT Pro BNP From Baseline to 30 Days
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for Pathway 1 (patients hospitalized with acute heart failure) Age >18 years Willingness and ability to provide informed consent 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 Persistent congestion 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 index hospitalization Orthopnea Total anticipated daily IV furosemide dose (at time of screening) >80-240 mg (or equivalent)/day Anticipated need for at least 24 more hours of parenteral diuretic therapy Exclusion Criteria for Pathway 1 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 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 Exclusion Criteria for Pathway 2 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Hernandez, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eugene Braunwald, MD
Organizational Affiliation
Harvard University
Official's Role
Study Chair
Facility Information:
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Saint Louis University Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
University Hospitals- Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Metro Health System
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pennsylvaina
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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