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Clinical Performance Evaluation of AQT90 FLEX BNP and NT-proBNP

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ClinicalTrials.gov Identifier: NCT01808872
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : May 5, 2014
Sponsor:
Information provided by (Responsible Party):
Radiometer Medical ApS

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.

Condition or disease
Heart Failure

Study Type : Observational
Actual Enrollment : 569 participants
Time Perspective: Prospective
Official Title: Clinical Sensitivity and Specificity Study of AQT90 FLEX BNP and NT-proBNP
Study Start Date : March 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Group/Cohort
Heart Failure



Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
Samples are retained only for this study (troubleshooting purposes).


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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects 21 years of age or older with heart failure
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808872


Locations
United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States, 27109
Sponsors and Collaborators
Radiometer Medical ApS

Responsible Party: Radiometer Medical ApS
ClinicalTrials.gov Identifier: NCT01808872     History of Changes
Other Study ID Numbers: DC-043652
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: May 5, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases