NCT01808872

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
569

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 5, 2014

Status Verified

May 1, 2014

Enrollment Period

1.1 years

First QC Date

March 7, 2013

Last Update Submit

May 2, 2014

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (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

    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.

    Single blood draw upon study entry

Study Arms (1)

Heart Failure

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects 21 years of age or older with heart failure

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2013

First Posted

March 11, 2013

Study Start

March 1, 2013

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

May 5, 2014

Record last verified: 2014-05

Locations

US(1)