Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Clinical Performance Evaluation of AQT90 FLEX BNP and NT-proBNP

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Radiometer Medical ApS
ClinicalTrials.gov Identifier:
NCT01808872
First received: March 7, 2013
Last updated: May 2, 2014
Last verified: May 2014

March 7, 2013
May 2, 2014
March 2013
April 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01808872 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Performance Evaluation of AQT90 FLEX BNP and NT-proBNP
Clinical Sensitivity and Specificity Study 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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Samples are retained only for this study (troubleshooting purposes).

Non-Probability Sample

Subjects 21 years of age or older with heart failure

Heart Failure
Not Provided
Heart Failure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
569
May 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01808872
DC-043652
No
Radiometer Medical ApS
Radiometer Medical ApS
Not Provided
Not Provided
Radiometer Medical ApS
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP