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

NCT03170219 | Terminated Phase 2 Results DMC FDA Drug FDA Device

• 1 other identifier: Pro00070619
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 16

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.

Conditions

Acute Heart Failure; Decompensated Heart Failure

Outcome Measures

Primary Outcomes (1)

• Patient Safety Measured by Serious Adverse Events

  measured by serious adverse events

  30 days

Secondary Outcomes (9)

• 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

Study Arms (2)

Subcutaneous Furosemide and sc2wear device

EXPERIMENTAL

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.

Combination Product: subcutaneous furosemide and sc2wear device

Usual Care

NO INTERVENTION

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.

Interventions

subcutaneous furosemide and sc2wear device COMBINATION_PRODUCT

subcutaneous furosemide administered via sc2wear device vs. standard of care

Subcutaneous Furosemide and sc2wear device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe renal dysfunction (eGFR\< 20 ml/min/1.73m2) within 24 hours of enrollment
• Requirement for inotropes (other than digoxin) or mechanical support during hospitalization
• Clinically significant electrical instability during hospitalization
• Anticipated need for ongoing intravenous therapies beyond diuretics (electrolyte repletion, vasodilators, antibiotics, etc.)
• Planned discharge to location other than home (e.g., hospice, skilled nursing facility, etc.)
• Anticipated cardiac transplantation or left ventricular assist device within the next 30 days
• Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, acute myocarditis, constrictive pericarditis or tamponade
• Known or anticipated pregnancy in the next 30 days
• Prior use of a subcutaneous furosemide pump or current use of any subcutaneous pump, on-body infusion devices or patients who give regimented injections at the intended site of the furosemide infusion device.
• Other psychosocial or physical barriers to following the protocol and using SQ pump device outside the hospital setting
• Known allergy to furosemide
• Known sensitivity or allergy to medical adhesive tape
• Enrollment or planned enrollment in another therapeutic clinical trial in next 3 months
• Presentation is for indication other than CHF
• Age \>18 years

Sponsors & Collaborators

• Adrian Hernandez: lead

Study Sites (16)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Saint Louis University Hospital

St Louis, Missouri, 63117, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

University Hospitals- Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Metro Health System

Cleveland, Ohio, 44109, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvaina

Philadelphia, Pennsylvania, 19104, United States

Location

University of Vermont

Burlington, Vermont, 05401, United States

Location

Results Point of Contact

• Title: Rachel Olson, Project Leader
• Organization: Duke Clinical Research Institute

rachel.e.olson@duke.edu

919-668-5590

Study Officials

• Adrian Hernandez, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Eugene Braunwald, MD

  Harvard University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: HFN Coordinating Center PI

Study Record Dates

• First Submitted: May 6, 2017
• First Posted: May 30, 2017
• Study Start: April 27, 2018
• Primary Completion: September 20, 2018
• Study Completion: September 20, 2018
• Last Updated: January 23, 2019
• Results First Posted: January 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)