Clinical Performance Evaluation of AQT90 FLEX BNP and NT-proBNP

Radiometer Medical ApS569 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

569

Conditions

Heart Failure

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Wake Forest University

Winston-Salem, North Carolina, United States

Outcomes

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

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.

Time frame: Single blood draw upon study entry

Data from ClinicalTrials.gov

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