Prospective Evaluation of the StatusFirst™ CHF NT-proBNP Device in Human Whole Blood and Plasma Samples (WB-13)

Nanogen

Status: Completed

Conditions: Congestive Heart Failure (CHF)

Study type: Observational

Funder types: Industry

Identifiers

NCT00734045

WB-13

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

450 participants in 2 patient groups

1

Description:

Subjects with diagnosed congestive heart failure

2

Description:

Subjects not diagnosed with congestive heart failure