NCT06905392

Brief Summary

The purpose of this study is to establish the correlation between sample matrices, and to determine the sample stability for the NTproBNP2 Test Kit on the AQT90 FLEX analyzer.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
2 countries

5 active sites

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

First Submitted

Initial submission to the registry

March 25, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

May 15, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2026

Completed
Last Updated

February 17, 2026

Status Verified

August 1, 2025

Enrollment Period

8 months

First QC Date

March 25, 2025

Last Update Submit

February 16, 2026

Conditions

Diagnostic Tests

Outcome Measures

Primary Outcomes (2)

  • Correlation

    To establish a correlation between sample matrices

    5 month

  • Stability

    To determine sample stability with the NTproBNP2 Test Kit on the AQT90 FLEX analyzer

    5 month

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient population with expected NT-proBNP concentrations within the measuring range of NTproBNP2 Test Kit.

You may qualify if:

  • Subjects must be able to understand given information and demonstrate willingness and ability to voluntarily give a signed, valid written informed consent to participate in the study.
  • Subjects must be 18 years of age or older.
  • Subjects with expected NT-proBNP concentrations within the measuring range of NTproBNP2 Test Kit.

You may not qualify if:

  • Subjects known to be pregnant or breast-feeding.
  • Subjects previously enrolled in the study.
  • Subject, who has withdrawn consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hennepin Healthcare (Research Institute/ Minneapolis Medical Research Foundation)

Minneapolis, Minnesota, 55404, United States

Location

Hospital Universitario Virgen de la Arrixaca

Murcia, Spain

Location

Clinica Universidad de Navarra

Pamplona, 31008, Spain

Location

Hospital Clinico Universitario de Santiago Compostela

Santiago de Compostela, Spain

Location

Servicio Andaluz de Salud (SAS) - Hospital San Juan de la Cruz

Ùbeda, Spain

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2025

First Posted

April 1, 2025

Study Start

May 15, 2025

Primary Completion

January 2, 2026

Study Completion

January 2, 2026

Last Updated

February 17, 2026

Record last verified: 2025-08

Locations

US(1)ES(4)