Back to resultsSubcutaneous Furosemide in Acute Decompensated Heart Failure Pilot (SUBQ-Pilot)
Primary Purpose
Acute Heart Failure
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Furosemide
Sponsored by
About this trial
This is an interventional treatment trial for Acute Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Age >18 years
- Willingness and ability to provide informed consent
- Hospitalization for acute heart failure (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, Brain Natriuretic Peptide > 250 ng/mL or N-terminal pro-brain natriuretic peptide (NTproBNP) > 1000 ng/mL) of congestion
Persistent congestion despite at least 18 hours of intravenous (IV) therapy, defined by the presence of at least 2 or more of the following at the time of consent:
- Peripheral edema
- Rales
- Elevated jugular venous pressure (JVP)
- Ascites
- BNP > 250 ng/mL or NTproBNP > 1000 ng/mL
- Total anticipated daily IV furosemide dose (at time of screening) >80-200 mg (or equivalent)/day
- Anticipated need for at least 24 more hours of parenteral diuretic therapy -
Exclusion Criteria:
- Severe renal dysfunction (Estimated Glomerular Filtration Rate (eGFR)< 30 ml/min/1.73m2)
- Requirement for inotropes (other than digoxin) or mechanical support during hospitalization
- Clinically significant electrical instability during hospitalization
- Ongoing need for other intravenous therapies beyond diuretics (vasodilators, antibiotics, etc.)
- Anticipated need for ongoing parenteral electrolyte repletion
- 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 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 a subcutaneous pump device outside the hospital setting
- Unable to accurately measure urine output
- Known allergy to furosemide
- Known sensitivity or allergy to medical adhesive tape
Sites / Locations
- Emory University Hospital
- Massachusetts General Hospital
- Mayo Clinic
- Duke University Medical Center
- Metro Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active
Arm Description
All subjects in the pilot study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.
Outcomes
Primary Outcome Measures
Overall Safety of a Strategy Based on Subcutaneous Delivery of Furosemide in Inpatients and Outpatients as Measured by Number of Adverse Events
The analysis of data from the Pilot Phase will be primarily descriptive in nature and there will be no formal hypothesis testing. Number of patients with events will be reported.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02877095
Brief Title
Subcutaneous Furosemide in Acute Decompensated Heart Failure Pilot
Acronym
SUBQ-Pilot
Official Title
Subcutaneous Furosemide in Acute Decompensated Heart Failure: The SUBQ-HF Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
December 19, 2016 (Actual)
Primary Completion Date
November 7, 2017 (Actual)
Study Completion Date
November 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Adrian Hernandez
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The Pilot study is designed to evaluate the overall safety and feasibility of a strategy based on subcutaneous delivery of furosemide. It will be used to inform the subsequent evaluation phase of the study (separate protocol). The primary objective of the study is to determine if a strategy of a novel subcutaneous delivery of furosemide is safe and feasible in patients with acute heart failure.
Detailed Description
Multi-center, open-label, pilot study conducted in 2 phases. Each phase will enroll 20 subjects that will be used to inform the study design of the SUBQ-HF Study (approximately 300 evaluable patients randomized to either usual inpatient care or early discharge with home subcutaneous furosemide for 1-7 days).
Inpatient Pilot Phase:
Eligible in-patients will be approached for participation. Subjects who consent for participation will be treated with subcutaneous furosemide for 48 hours, during which they will remain in the hospital. This will be primarily a safety and feasibility assessment. There will be no formal hypothesis tested, and statistical analysis will be descriptive in nature.
Outpatient Pilot Phase:
Eligible in-patients who are nearing discharge will be approached for participation. Subjects who consent for participation will be instructed on use of device, discharged to home and treated at home with subcutaneous furosemide for 1-7 days. This will be primarily a safety and feasibility assessment. There will be no formal hypothesis tested, and statistical analysis will be descriptive in nature.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
All subjects in the pilot study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Furosemide
Other Intervention Name(s)
Lasix
Intervention Description
subcutaneous furosemide delivered via subcutaneous pump
Primary Outcome Measure Information:
Title
Overall Safety of a Strategy Based on Subcutaneous Delivery of Furosemide in Inpatients and Outpatients as Measured by Number of Adverse Events
Description
The analysis of data from the Pilot Phase will be primarily descriptive in nature and there will be no formal hypothesis testing. Number of patients with events will be reported.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >18 years
Willingness and ability to provide informed consent
Hospitalization for acute heart failure (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, Brain Natriuretic Peptide > 250 ng/mL or N-terminal pro-brain natriuretic peptide (NTproBNP) > 1000 ng/mL) of congestion
Persistent congestion despite at least 18 hours of intravenous (IV) therapy, defined by the presence of at least 2 or more of the following at the time of consent:
Peripheral edema
Rales
Elevated jugular venous pressure (JVP)
Ascites
BNP > 250 ng/mL or NTproBNP > 1000 ng/mL
Total anticipated daily IV furosemide dose (at time of screening) >80-200 mg (or equivalent)/day
Anticipated need for at least 24 more hours of parenteral diuretic therapy -
Exclusion Criteria:
Severe renal dysfunction (Estimated Glomerular Filtration Rate (eGFR)< 30 ml/min/1.73m2)
Requirement for inotropes (other than digoxin) or mechanical support during hospitalization
Clinically significant electrical instability during hospitalization
Ongoing need for other intravenous therapies beyond diuretics (vasodilators, antibiotics, etc.)
Anticipated need for ongoing parenteral electrolyte repletion
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 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 a subcutaneous pump device outside the hospital setting
Unable to accurately measure urine output
Known allergy to furosemide
Known sensitivity or allergy to medical adhesive tape
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
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Metro Health System
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
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Subcutaneous Furosemide in Acute Decompensated Heart Failure Pilot
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