Clinical Performance Evaluation of AQT90 FLEX BNP and NT-proBNP

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Determination of the clinical sensitivity and specificity of the AQT90 FLEX BNP and NT-proBNP assays at the clinical cut-off in heart failure patients

Time frame: Single blood draw upon study entry

Clinical sensitivity and specificity with 95 % confidence intervals of the AQT90 FLEX BNP and NT-proBNP assays will be determined at the clinical cut-off in heart failure patients divided by age, gender and New York Heart Association (NYHA) functional classification.

Sponsors and collaborators

Lead sponsor

Radiometer Medical ApS

Industry

Registry information

Official study title

Clinical Sensitivity and Specificity Study of AQT90 FLEX BNP and NT-proBNP

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Mar 11, 2013
Registry last updated: May 5, 2014

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.

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Completed