Acute Heart Failure Clinical Trial
Official title:
Subcutaneous Furosemide in Acute Decompensated Heart Failure: The SUBQ-HF Pilot Study
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.
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.
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