NCT02614209

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 25, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 10, 2016

Status Verified

November 1, 2015

Enrollment Period

1.3 years

First QC Date

November 6, 2015

Last Update Submit

August 9, 2016

Conditions

Heart Failure

Keywords

EDBNP

Outcome Measures

Primary Outcomes (1)

  • Measure BNP

    400 subjects

    6 months

Interventions

In Vitro diagnostic testsDEVICE

Prospective blood collection

Also known as: Propective collection for use in InVitro diagnostic studies

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to ED and prescribed a BNP with or without HF

You may qualify if:

  • Males and females \>21 years of age
  • Able to understand and willing to provide informed consent
  • Present in to ED
  • BNP test requested

You may not qualify if:

  • Males and females\< 21 years
  • Unable to provide informed consent
  • Not presenting to ED
  • hemolyzed sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Diana Dickson, RAC

    Fujirebio Diagnostics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2015

First Posted

November 25, 2015

Study Start

May 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 10, 2016

Record last verified: 2015-11

Locations

US(2)