Heart FailureRINCT06834880
AQT90 FLEX NTproBNP2 Test Kit - 23004 - Reference Interval Study
An observational study of Heart Failure, run by Radiometer Medical ApS at 1 site in Finland.
Trial summary
The purpose of this study is to establish the overall (age- and sex independent) at least 95th percentile upper reference limit (URL) of the NTproBNP2 Test Kit on the AQT90 FLEX analyzer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- Type of treatment
- Medical device
- How many people
- 781 participants
- Where
- 1 siteFinland
- Study dates
- 27 Jan 2025to 5 Feb 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A minimum of 351 apparently healthy subjects in total and an approximately equal sex distribution is required for the study (i.e., approximately 50% male and 50% female population). The expected age range is from 18 and up to 90 years.
Who may be able to join
- Subject must have given their valid consent to donate their sample in the sample bank
- Subjects must have been 18 years of age or older at the time of sample collection
- Subject must have answered yes, to being generally healthy, in the health questionnaire
- Subjects must, as a minimum, have completed questions regarding age, gender, race, and ethnicity
Who cannot join
- Answered yes to any of the conditions below (Information gathered from a self-reported health questionnaire or results from blood sample tests):
- Current medications for treating cardiovascular diseases at the time of sample collection
- Current antibiotics (Indicates ongoing infections)
- Known to suffer from any of the illnesses below at the time of sample collection:
- Disease(s) of/or affecting the cardiovascular system
- Congestive heart failure
Show all 11Show fewer
- Hypertension
- Previous history of any heart disease
- Diabetes (Either self-reported in questionnaire or a glycosylated hemoglobin (HbA1C) in the diabetic range (above 6.4%)
- Renal dysfunction or failure (An estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73m2.) This is to be calculated using information on age, sex and creatinine using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine equation.
- Cancer or history of cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AQT90 FLEX NTproBNP2 Test Kit - 23004 - Reference Interval Study Protocol
The purpose of this study is to establish the overall (age- and sex independent) at least 95th percentile upper reference limit (URL) of the NTproBNP2 Test Kit on the AQT90 FLEX analyzer.
Read the detailed description
The NTproBNP2 Test is an in vitro diagnostic assay for the quantitative determination of N-terminal pro-B-type natriuretic peptide {NT-proBNP) in EDTA or lithium heparin whole blood or plasma specimens on the AQT90 FLEX analyzer in point of care/ near-patient testing and laboratory settings. It is intended for use as an aid in the diagnosis of heart failure. The test is also intended for use as an aid in the risk stratification of patients with acute coronary syndrome and heart failure.
The NTproBNP2 CAL Cartridge is an in vitro diagnostic reagent intended for the calibration adjustment of the NTproBNP2 Test on the AQT90 FLEX analyzer by establishing points of reference to estimate NT-proBNP values.
The AQT90 FLEX analyzer is an immunoassay instrument based on the quantitative determination of time-resolved fluorescence to estimate the concentrations of clinically relevant markers on whole-blood and plasma specimens to which a relevant anticoagulant has been added. It is intended for use in point of care/ near-patient testing and laboratory settings.
- Conditions
- Heart Failure
- Being tested
- No intervention; Observational study
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention; Observational studyDevice
Sample bank with Health Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Healthy population | ADLM universal sample bank from healthy individuals are used in the study. Receives: Device: No intervention; Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
95th percentile of normal concentrations with 95% confidence intervals (CI) for overall samples
The primary endpoint of this study is to establish at least 95th percentile of normal concentrations with 95% confidence intervals (CI) for overall samples for the AQT90 FLEX NTproBNP2 Test Kit by analyzing LiHep plasma samples collected from apparently healthy subjects.
Measured: Baseline
Secondary outcomes (1)
95th percentile for normal concentrations separately for both males and females
The secondary endpoint would be to establish the 95th percentile for normal concentrations separately for both males and females with the 95% confidence intervals.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start27 Jan 2025
- Primary completion5 Feb 2025
- Study completion5 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 781 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Radiometer Medical ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834880
- Sponsor's protocol ID
- DC-087455
- Acronym
- RI
- Status last verified
- Aug 2025
- First submitted
- 6 Feb 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AQT90 FLEX NTproBNP2 Test Kit - 23004 - Reference Interval Study Protocol
- ClinicalTrials.gov ID
- NCT06834880
- Acronym / sponsor ID
- RI / DC-087455
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 781 participants (actual)
- Lead sponsor
- Radiometer Medical ApSIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to establish the overall (age- and sex independent) at least 95th percentile upper reference limit (URL) of the NTproBNP2 Test Kit on the AQT90 FLEX analyzer.
Detailed description
The NTproBNP2 Test is an in vitro diagnostic assay for the quantitative determination of N-terminal pro-B-type natriuretic peptide {NT-proBNP) in EDTA or lithium heparin whole blood or plasma specimens on the AQT90 FLEX analyzer in point of care/ near-patient testing and laboratory settings. It is intended for use as an aid in the diagnosis of heart failure. The test is also intended for use as an aid in the risk stratification of patients with acute coronary syndrome and heart failure.
The NTproBNP2 CAL Cartridge is an in vitro diagnostic reagent intended for the calibration adjustment of the NTproBNP2 Test on the AQT90 FLEX analyzer by establishing points of reference to estimate NT-proBNP values.
The AQT90 FLEX analyzer is an immunoassay instrument based on the quantitative determination of time-resolved fluorescence to estimate the concentrations of clinically relevant markers on whole-blood and plasma specimens to which a relevant anticoagulant has been added. It is intended for use in point of care/ near-patient testing and laboratory settings.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy population | – | Device: No intervention; Observational studyADLM universal sample bank from healthy individuals are used in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A minimum of 351 apparently healthy subjects in total and an approximately equal sex distribution is required for the study (i.e., approximately 50% male and 50% female population). The expected age range is from 18 and up to 90 years.
Key inclusion criteria (4 listed)
- Subject must have given their valid consent to donate their sample in the sample bank
- Subjects must have been 18 years of age or older at the time of sample collection
- Subject must have answered yes, to being generally healthy, in the health questionnaire
- Subjects must, as a minimum, have completed questions regarding age, gender, race, and ethnicity
Key exclusion criteria (11 listed)
- Answered yes to any of the conditions below (Information gathered from a self-reported health questionnaire or results from blood sample tests):
- Current medications for treating cardiovascular diseases at the time of sample collection
- Current antibiotics (Indicates ongoing infections)
- Known to suffer from any of the illnesses below at the time of sample collection:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention; Observational studySample bank with Health Questionnaire | Device | Healthy population |
Primary outcome
95th percentile of normal concentrations with 95% confidence intervals (CI) for overall samples
Time frame: Baseline
The primary endpoint of this study is to establish at least 95th percentile of normal concentrations with 95% confidence intervals (CI) for overall samples for the AQT90 FLEX NTproBNP2 Test Kit by analyzing LiHep plasma samples collected from apparently healthy subjects.
1 secondary outcome
95th percentile for normal concentrations separately for both males and females
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
Related trials for Heart Failure
Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
RecruitingPhase 3
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Radiometer Medical ApS at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
95th percentile of normal concentrations with 95% confidence intervals (CI) for overall samples (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.