Blood Collection of Patient Presenting in the ED and Prescribed a BNP

Heart Failure Clinical Trial

— BNP  

Official title:

A Blood Collection From Patients Presenting in the Emergency Department and Prescribed a Brain Natriuretic Peptide (BNP) Laboratory Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02614209
• Other study ID #: FDI-120
• Status: Completed
• Phase: N/A
• First received: November 6, 2015
• Last updated: August 9, 2016
• Start date: May 2015
• Est. completion date: August 2016

Study information

• Verified date: November 2015
• Source: Fujirebio Diagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Plasma specimen collected from patients presenting in the Emergency Department (ED) with or without Heart Failure (HF) and prescribed a BNP.

Description:

Plasma samples are collected from a minimum of 400 subjects. Specimens are used to confirm the currently accepted BNP cut off as and aid in the diagnosis and assessment of HF.

Stored specimens for future use in BNP assay development.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Males and females >21 years of age

• Able to understand and willing to provide informed consent

• Present in to ED

• BNP test requested

Exclusion Criteria:

• Males and females< 21 years

• Unable to provide informed consent

• Not presenting to ED

• hemolyzed sample

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• In Vitro diagnostic tests
Prospective blood collection

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	Henry Ford Health System	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Fujirebio Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure BNP	400 subjects	6 months	No