Subcutaneous Furosemide in Acute Decompensated Heart Failure: The SUBQ-HF Study
- Conditions
- Decompensated Heart FailureAcute Heart Failure
- Interventions
- Combination Product: subcutaneous furosemide and sc2wear device
- Registration Number
- NCT03170219
- Lead Sponsor
- Adrian Hernandez
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 11
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Subcutaneous Furosemide and sc2wear device 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.
- Primary Outcome Measures
Name Time Method Patient Safety Measured by Serious Adverse Events 30 days measured by serious adverse events
- Secondary Outcome Measures
Name Time Method Composite Safety Endpoint of Death, Sustained Ventricular Arrhythmias, and Severe Hypokalemia 30 days Medical Costs From Randomization Through 30 Days 30 days Days Alive and Outside the Hospital Through 14 Days 14 days 30 Day Heart Failure Readmission 30 days 30 Day ED Visit for Heart Failure 30 days Death at 30 Days 30 days Change in Breathlessness Through Day 7 7 days On a 0-10 scale of breathlessness
Change in Renal Function Using eGFR Baseline to 30 Days 30 days Change in NT Pro BNP From Baseline to 30 Days 30 days
Trial Locations
- Locations (16)
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University of Vermont
🇺🇸Burlington, Vermont, United States
Duke University
🇺🇸Durham, North Carolina, United States
Saint Louis University Hospital
🇺🇸Saint Louis, Missouri, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University Hospitals- Case Medical Center
🇺🇸Cleveland, Ohio, United States
University of Pennsylvaina
🇺🇸Philadelphia, Pennsylvania, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Metro Health System
🇺🇸Cleveland, Ohio, United States