Clinical Performance Evaluation of AQT90 FLEX BNP and NT-proBNP

Completed

Conditions studied: Heart Failure

In brief

The AQT90 FLEX B-type Natriuretic Peptide (BNP) and N-terminal pro B-type natriuretic peptide (NT-proBNP) Tests are in vitro diagnostic assays intended as an aid in the diagnosis and assessment of the severity of heart failure in point-of-care and laboratory settings. The purpose of the study is to establish the clinical performance of the AQT90 FLEX BNP and NT-proBNP assays for both whole blood and plasma in the intended use population.

Key facts

Study ID

NCT01808872

Run by

Radiometer Medical ApS

People needed

569

Starts

2013-03-01

Expected to finish

2014-05-01

Last updated by the study team

2014-05-05

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is 21 years of age or older
• Subject is able to understand information given, and willing and able to voluntarily give their consent to participate in this study
• Subject has diagnosis of heart failure

You may not qualify if…

• Subject has Acute Coronary Syndrome (ACS)
• Subject has been diagnosed and/or treated for malignancy within past 6 months
• Subject has had cardiac surgery within the past 4 weeks
• Subject claim of pregnancy
• Subject's prior participation in this study

Where it is running

• Wake Forest University — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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