Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 242 for:    furosemide

Subcutaneous Furosemide in Acute Decompensated Heart Failure Pilot (SUBQ-Pilot)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02877095
Recruitment Status : Completed
First Posted : August 24, 2016
Results First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Adrian Hernandez, Duke University

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Heart Failure Drug: Furosemide Phase 1

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Furosemide

Arm Intervention/treatment
Experimental: Active
All subjects in the pilot study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.
Drug: Furosemide
subcutaneous furosemide delivered via subcutaneous pump
Other Name: Lasix




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >18 years
  2. Willingness and ability to provide informed consent
  3. Hospitalization for acute heart failure (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, Brain Natriuretic Peptide > 250 ng/mL or N-terminal pro-brain natriuretic peptide (NTproBNP) > 1000 ng/mL) of congestion
  4. Persistent congestion despite at least 18 hours of intravenous (IV) therapy, defined by the presence of at least 2 or more of the following at the time of consent:

    • Peripheral edema
    • Rales
    • Elevated jugular venous pressure (JVP)
    • Ascites
    • BNP > 250 ng/mL or NTproBNP > 1000 ng/mL
  5. Total anticipated daily IV furosemide dose (at time of screening) >80-200 mg (or equivalent)/day
  6. Anticipated need for at least 24 more hours of parenteral diuretic therapy -

Exclusion Criteria:

  1. Severe renal dysfunction (Estimated Glomerular Filtration Rate (eGFR)< 30 ml/min/1.73m2)
  2. Requirement for inotropes (other than digoxin) or mechanical support during hospitalization
  3. Clinically significant electrical instability during hospitalization
  4. Ongoing need for other intravenous therapies beyond diuretics (vasodilators, antibiotics, etc.)
  5. Anticipated need for ongoing parenteral electrolyte repletion
  6. Planned discharge to location other than home (e.g, hospice, skilled nursing facility, etc.)
  7. Anticipated cardiac transplantation or left ventricular assist device within the next 30 days
  8. Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, acute myocarditis, constrictive pericarditis or tamponade
  9. Known or anticipated pregnancy in the next 30 days Prior use of 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
  10. Other psychosocial or physical barriers to following the protocol and using a subcutaneous pump device outside the hospital setting
  11. Unable to accurately measure urine output
  12. Known allergy to furosemide
  13. Known sensitivity or allergy to medical adhesive tape

Information from the National Library of Medicine

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


Locations
Layout table for location information
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
Mayo Clinic
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
Sponsors and Collaborators
Adrian Hernandez
Investigators
Layout table for investigator information
Principal Investigator: Adrian Hernandez, MD Duke University
Study Chair: Eugene Braunwald, MD Harvard University
  Study Documents (Full-Text)

Documents provided by Adrian Hernandez, Duke University:

Layout table for additonal information
Responsible Party: Adrian Hernandez, HFN Coordinating Center PI, Duke University
ClinicalTrials.gov Identifier: NCT02877095     History of Changes
Other Study ID Numbers: Pro00070399
First Posted: August 24, 2016    Key Record Dates
Results First Posted: March 15, 2019
Last Update Posted: March 15, 2019
Last Verified: November 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases
Furosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action