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
  Purpose

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
Heart Failure

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Clinical Sensitivity and Specificity Study of AQT90 FLEX BNP and NT-proBNP

Resource links provided by NLM:


Further study details as provided by Radiometer Medical ApS:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA

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


Enrollment: 569
Study Start Date: March 2013
Study Completion Date: May 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Heart Failure

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01808872

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

No publications provided

Responsible Party: Radiometer Medical ApS
ClinicalTrials.gov Identifier: NCT01808872     History of Changes
Other Study ID Numbers: DC-043652
Study First Received: March 7, 2013
Last Updated: May 2, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 29, 2014