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

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.

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Key information

Conditions

Congestive Heart Failure (CHF) Cardiovascular Diseases Heart Diseases Heart Failure

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

US Department of Veteran's Affairs, San Diego, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

StatusFirst CHF NT-proBNP test result

Time frame: At presentation to study site (no follow-up)

Sponsors and collaborators

Lead sponsor

Nanogen, Inc.

Industry

Registry information

Acronym: WB-13

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Aug 13, 2008
Registry last updated: Dec 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed