HealthyNCT03102944
Determining Normal Values of BNP Levels for the Minicare BNP IVD Assay.
An observational study of Healthy, run by Philips Handheld Diagnostics at 1 site in Netherlands.
Trial summary
Main objective is to determine normal values for Brain Natriuretic Peptide (BNP) levels for the Minicare BNP using K2-EDTA (ethylenediaminetetraacetic acid ) venous whole blood and K2-EDTA plasma samples from healthy subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Minicare BNP
- How many people
- 160 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Mar 2017to 24 Mar 2017
- 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: Healthy volunteers
Who may be able to join
- ≥18 years old
- Willing and able to sign the informed consent form (ICF)
Who cannot join
- Subjects suffering from cardiac and/or vascular disease, renal dysfunction, hypertension, cancer, Chronic Obstructive Pulmonary Disease (COPD), instable diabetes, pregnancy and extreme overweight are not allowed to donate blood.
- Subjects with a history of cardiac and/or vascular disease, renal dysfunction, cancer, COPD or instable diabetes are not allowed to donate blood.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minicare BNP Normal Value Study - MI-BNP-CE02-NV2016
Main objective is to determine normal values for Brain Natriuretic Peptide (BNP) levels for the Minicare BNP using K2-EDTA (ethylenediaminetetraacetic acid ) venous whole blood and K2-EDTA plasma samples from healthy subjects.
K2-EDTA whole blood and K2-EDTA plasma samples from approximately 150 normal healthy volunteer, preferably 50% men and 50% women, will be analysed using the Minicare BNP system. This will be a single-center study. The study will consist of a 1-day visit for each study subject on which screening based on a questionnaire, blood draw and discharge will occur. For each eligible subject, K2-EDTA whole blood will be collected and both K2-EDTA whole blood and K2-EDTA plasma will be analyzed using the Minicare BNP. Blood donors, presenting voluntarily at one of the Sanquin posts in, the Netherlands (e.g Eindhoven) will be checked on health status and selected based on 2 questionnaires. The collected K2-EDTA whole blood tubes from eligible subjects will be transferred from the Sanquin posts to Philips Eindhoven for Minicare BNP testing. From one subject, both K2-EDTA whole blood and K2-EDTA plasma will be measured in singleton. K2-EDTA whole blood and plasma will be measured within 6 hours after blood collection. The data obtained will be used for determination of normal values of BNP in a healthy population. Leftover plasma samples (without cells/ RNA/DNA) will be aliquoted and stored at Philips for potential future analysis/ projects). Testing will be done according to a DRAFT Instructions for use (IFU) of the Minicare BNP.
- Conditions
- Healthy
- Being tested
- Minicare BNP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minicare BNPDiagnostic test
no real intervention since only leftover materials are used from volunteers and samples are not tested on Minicare BNP IVD device near any volunteer.
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | no intervention, extra blood tube taken with blood donation at bloodbank and blood is tested on IVD away from patient. Receives: Diagnostic Test: Minicare BNP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal values for BNP for the Minicare BNP
To determine normal values for BNP levels for the Minicare BNP using K2- EDTA venous whole blood and K2-EDTA plasma samples from healthy subjects.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start21 Mar 2017
- Primary completion24 Mar 2017
- Study completion24 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Handheld Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diederick Keizer, Study chair, Clinical Affairs Manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102944
- Sponsor's protocol ID
- HHDx-07998
- Status last verified
- Mar 2017
- First submitted
- 31 Mar 2017
- Last updated
- 18 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minicare BNP Normal Value Study - MI-BNP-CE02-NV2016
- ClinicalTrials.gov ID
- NCT03102944
- Acronym / sponsor ID
- HHDx-07998
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Philips Handheld DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- 24 Mar 2017 (actual)
- Study completion
- 24 Mar 2017 (actual)
- First posted
- 6 Apr 2017 (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.
Main objective is to determine normal values for Brain Natriuretic Peptide (BNP) levels for the Minicare BNP using K2-EDTA (ethylenediaminetetraacetic acid ) venous whole blood and K2-EDTA plasma samples from healthy subjects.
K2-EDTA whole blood and K2-EDTA plasma samples from approximately 150 normal healthy volunteer, preferably 50% men and 50% women, will be analysed using the Minicare BNP system. This will be a single-center study. The study will consist of a 1-day visit for each study subject on which screening based on a questionnaire, blood draw and discharge will occur. For each eligible subject, K2-EDTA whole blood will be collected and both K2-EDTA whole blood and K2-EDTA plasma will be analyzed using the Minicare BNP. Blood donors, presenting voluntarily at one of the Sanquin posts in, the Netherlands (e.g Eindhoven) will be checked on health status and selected based on 2 questionnaires. The collected K2-EDTA whole blood tubes from eligible subjects will be transferred from the Sanquin posts to Philips Eindhoven for Minicare BNP testing. From one subject, both K2-EDTA whole blood and K2-EDTA plasma will be measured in singleton. K2-EDTA whole blood and plasma will be measured within 6 hours after blood collection. The data obtained will be used for determination of normal values of BNP in a healthy population. Leftover plasma samples (without cells/ RNA/DNA) will be aliquoted and stored at Philips for potential future analysis/ projects). Testing will be done according to a DRAFT Instructions for use (IFU) of the Minicare BNP.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | – | Diagnostic Test: Minicare BNPno intervention, extra blood tube taken with blood donation at bloodbank and blood is tested on IVD away from patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (2 listed)
- ≥18 years old
- Willing and able to sign the informed consent form (ICF)
Key exclusion criteria (2 listed)
- Subjects suffering from cardiac and/or vascular disease, renal dysfunction, hypertension, cancer, Chronic Obstructive Pulmonary Disease (COPD), instable diabetes, pregnancy and extreme overweight are not allowed to donate blood.
- Subjects with a history of cardiac and/or vascular disease, renal dysfunction, cancer, COPD or instable diabetes are not allowed to donate blood.
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 |
|---|---|---|
| Minicare BNPno real intervention since only leftover materials are used from volunteers and samples are not tested on Minicare BNP IVD device near any volunteer. | Diagnostic test | healthy volunteers |
Primary outcome
Normal values for BNP for the Minicare BNP
Time frame: 4 weeks
To determine normal values for BNP levels for the Minicare BNP using K2- EDTA venous whole blood and K2-EDTA plasma samples from healthy subjects.
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 18 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Diederick Keizer study chair
Clinical Affairs Manager
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 Healthy, run by Philips Handheld Diagnostics at 1 site in Netherlands.
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 2 inclusion and 2 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 18 Oct 2017. 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 Netherlands. 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?
Normal values for BNP for the Minicare BNP (time frame: 4 weeks). 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 18 Oct 2017.