Subcutaneous Furosemide in Acute Decompensated Heart Failure Pilot

NCT02877095 | Completed Phase 1 Results DMC

• 1 other identifier: Pro00070399
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

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.

Conditions

Acute Heart Failure

Outcome Measures

Primary Outcomes (1)

• Overall Safety of a Strategy Based on Subcutaneous Delivery of Furosemide in Inpatients and Outpatients as Measured by Number of Adverse Events

  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.

  14 days

Study Arms (1)

Active

EXPERIMENTAL

All subjects in the pilot study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.

Drug: Furosemide

Interventions

Furosemide DRUG

subcutaneous furosemide delivered via subcutaneous pump

Also known as: Lasix

Active

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 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
• 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
• Total anticipated daily IV furosemide dose (at time of screening) \>80-200 mg (or equivalent)/day
• Anticipated need for at least 24 more hours of parenteral diuretic therapy -

You may not qualify if:

• Severe renal dysfunction (Estimated Glomerular Filtration Rate (eGFR)\< 30 ml/min/1.73m2)
• Requirement for inotropes (other than digoxin) or mechanical support during hospitalization
• Clinically significant electrical instability during hospitalization
• Ongoing need for other intravenous therapies beyond diuretics (vasodilators, antibiotics, etc.)
• Anticipated need for ongoing parenteral electrolyte repletion
• 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 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 a subcutaneous pump device outside the hospital setting
• Unable to accurately measure urine output
• Known allergy to furosemide
• Known sensitivity or allergy to medical adhesive tape

Sponsors & Collaborators

• Adrian Hernandez: lead

Study Sites (5)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Metro Health System

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

Furosemide

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Results Point of Contact

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

rachel.e.olson@duke.edu

919-309-5544

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 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: HFN Coordinating Center PI

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: August 24, 2016
• Study Start: December 19, 2016
• Primary Completion: November 7, 2017
• Study Completion: November 7, 2017
• Last Updated: March 15, 2019
• Results First Posted: March 15, 2019

Record last verified: 2018-11

Locations

US (5)