Clinical Performance Evaluation of AQT90 FLEX BNP and NT-proBNP

This study is currently recruiting participants.
Verified March 2014 by Radiometer Medical ApS
Sponsor:
Information provided by (Responsible Party):
Radiometer Medical ApS
ClinicalTrials.gov Identifier:
NCT01808872
First received: March 7, 2013
Last updated: March 21, 2014
Last verified: March 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).


Estimated Enrollment: 400
Study Start Date: March 2013
Estimated Study Completion Date: April 2014
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01808872

Locations
United States, North Carolina
Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27109
Contact: Brian Hiestand, MD    336-716-3617    bhiestan@wakehealth.edu   
Principal Investigator: Brian Hiestand, MD         
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: March 21, 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 April 16, 2014