Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06963619

AQT90 FLEX NTproBNP (N-terminal Pro-brain Natriuretic Peptide) 2 Test Kit - Reference Interval Study Protocol - China

To establish the reference range of the NTproBNP2 Test Kit (time-resolved immunofluorescence method) in apparently healthy Chinese population.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects who meet all the following criteria are eligible for inclusion:

  • Voluntarily participate in this study and sign informed consent;
  • Body Mass Index (BMI) ≥18.5 and <28kg/ m2;
  • Age ≥18 years old;
  • Through the investigator's consultation with the subjects, evaluate the subjects who meet the requirements of the reference individual of this study (refer to the "reference individual questionnaire").

Exclusion criteria

Subjects who meet any of the following criteria will be excluded:

  • Physical examination, laboratory test/examination results meet any of the following:
  • eGFR(estimated glomerular filtration rate) (formula: CKD-EPI, chronic kidney disease epidemiology collaboration) < 60 mL/min/1.732
  • Systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥80 mmHg
  • Glycated hemoglobin A1c (HbA1c) ≥ 6.0%; or fasting blood glucose ≥ 7.0 mmol/L
  • Total cholesterol ≥ 6.22 mmol/L and/or triglycerides ≥ 2.26 mmol/L
  • High-sensitivity troponin: Female: ≥15.6 pg/mL (ng/L), Male: ≥34.2 pg/mL (ng/L)
  • Electrocardiogram, with obvious abnormalities such as those that may cause cardiac structural changes or risk factors for arrhythmia as assessed by the investigator
  • Subjects who are unable to provide a sufficient volume (≈2 mL) of EDTAanticoagulated whole blood sample;
  • Subjects who withdraw informed consent;
  • Subjects assessed by the investigator as unsuitable for inclusion in this study.

Treatment and study plan

Primary outcomes

  1. AQT90 FLEX NTproBNP2 Test Kit - Reference Interval Establishment - China

    Time frame: 12 months

    To establish the reference range of the NTproBNP2 Test Kit (time-resolved immunofluorescence method) in apparently healthy Chinese population.

Sponsors and collaborators

Lead sponsor

Radiometer Medical ApS

Industry

Registry information

Official study title

NTproBNP2 Test Kit (Time-Resolved Immunofluorescence Method) Reference Interval Establishment Study Protocol

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 9, 2025
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.