Prospective Evaluation of the StatusFirst™ CHF NT-proBNP Device in Human Whole Blood and Plasma Samples

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00734045

Acronym

WB-13

Enrollment

450

Registered

2008-08-13

Start date

2008-02-29

Completion date

2008-11-30

Last updated

2008-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure (CHF)

Keywords

Congestive Heart Failure (CHF), NT-proBNP

Brief summary

The primary objective of the study is to establish the correlation between NT-proBNP measurements in fresh human whole blood samples and those in plasma samples from the same study subjects, where said samples are collected in EDTA and Li-Hep anticoagulant tubes and measured by the StatusFirst™ CHF NT-proBNP device in conjunction with the DXpressTM Reader in a laboratory setting.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Have clinically confirmed heart failure (NYHA class I-IV) or have presented to an emergency room or clinic with signs, symptoms and/or risk factors suggestive of heart failure, OR * Be non-CHF controls greater than 45 years of age with no history of heart failure or cardiovascular disease.

Exclusion criteria

* Be 45 years of age or younger

Design outcomes

Primary

Measure	Time frame
StatusFirst CHF NT-proBNP test result	At presentation to study site (no follow-up)

Countries

United States

Outcome results