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

Status: Terminated
Location: See all (16) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \>18 years

• Willingness and ability to provide informed consent

• Hospitalization for 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, BNP \> 250 ng/mL or NTproBNP \> 1000 ng/mL) of congestion

• Persistent congestion defined by the presence of at least 2 or more of the following at the time of consent:

‣ Peripheral edema

⁃ Rales

⁃ Elevated JVP

⁃ Ascites

⁃ BNP \> 250 ng/mL or NTproBNP \> 1000 ng/mL during index hospitalization

⁃ Orthopnea

• Total anticipated daily IV furosemide dose (at time of screening) \>80-240 mg (or equivalent)/day

• Anticipated need for at least 24 more hours of parenteral diuretic therapy

• Age \>18 years

• Willingness and ability to provide informed consent

• HF now presenting with volume overload defined by the presence of at least 2 or more of the following at the time of consent:

‣ Peripheral edema

⁃ Rales

⁃ Elevated JVP

⁃ Ascites

⁃ BNP \> 250 ng/mL or NTproBNP \> 1000 ng/mL during this episode of decompensation

⁃ Orthopnea

• Need for parenteral furosemide with an estimated SQ furosemide requirement between 80-240 mg/day

• Anticipated need for at least 24 hours of parenteral diuretic therapy

Locations
United States
Georgia
Emory University Hospital
Atlanta
Illinois
Northwestern University
Chicago
Massachusetts
Brigham and Women's Hospital
Boston
Massachusetts General Hospital
Boston
Tufts Medical Center
Boston
Maryland
Johns Hopkins Hospital
Baltimore
Minnesota
Mayo Clinic
Rochester
Missouri
Saint Louis University Hospital
Saint Louis
Washington University
Saint Louis
North Carolina
Duke University
Durham
New York
Stony Brook University Medical Center
Stony Brook
Ohio
Cleveland Clinic
Cleveland
Metro Health System
Cleveland
University Hospitals- Case Medical Center
Cleveland
Pennsylvania
University of Pennsylvaina
Philadelphia
Vermont
University of Vermont
Burlington
Time Frame
Start Date: 2018-04-27
Completion Date: 2018-09-20
Participants
Target number of participants: 11
Treatments
Experimental: 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.
No_intervention: Usual Care
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.
Related Therapeutic Areas
Sponsors
Leads: Adrian Hernandez

This content was sourced from clinicaltrials.gov

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