NCT02877095

Subcutaneous Furosemide in Acute Decompensated Heart Failure Pilot

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Adrian Hernandez · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Heart Failure

Interventions

Type	Name	Description
DRUG	Furosemide	subcutaneous furosemide delivered via subcutaneous pump

Timeline

• Start date: 2016-12-19
• Primary completion: 2017-11-07
• Completion: 2017-11-07
• First posted: 2016-08-24
• Last updated: 2019-03-15
• Results posted: 2019-03-15

Locations

5 sites across 1 country: United States