Subcutaneous Furosemide in Acute Decompensated Heart Failure Pilot (SUBQ-Pilot)
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|ClinicalTrials.gov Identifier: NCT02877095|
Recruitment Status : Completed
First Posted : August 24, 2016
Results First Posted : March 15, 2019
Last Update Posted : March 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Heart Failure||Drug: Furosemide||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Subcutaneous Furosemide in Acute Decompensated Heart Failure: The SUBQ-HF Pilot Study|
|Actual Study Start Date :||December 19, 2016|
|Actual Primary Completion Date :||November 7, 2017|
|Actual Study Completion Date :||November 7, 2017|
All subjects in the pilot study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.
subcutaneous furosemide delivered via subcutaneous pump
Other Name: Lasix
- Overall Safety of a Strategy Based on Subcutaneous Delivery of Furosemide in Inpatients and Outpatients as Measured by Number of Adverse Events [ Time Frame: 14 days ]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.
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): NCT02877095
|United States, Georgia|
|Emory University Hospital|
|Atlanta, Georgia, United States, 30322|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27705|
|United States, Ohio|
|Metro Health System|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Adrian Hernandez, MD||Duke University|
|Study Chair:||Eugene Braunwald, MD||Harvard University|