Heart Failure
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Radiometer Medical ApS
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United States
Outcome results
None listed