Heart FailureBNPNCT02614209
Blood Collection of Patient Presenting in the ED and Prescribed a BNP
An observational study of Heart Failure, run by Fujirebio Diagnostics, Inc. at 2 sites in United States.
Trial summary
Plasma specimen collected from patients presenting in the Emergency Department (ED) with or without Heart Failure (HF) and prescribed a BNP. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- In Vitro diagnostic tests
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2015to Aug 2016
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to ED and prescribed a BNP with or without HF
Who may be able to join
- Males and females >21 years of age
- Able to understand and willing to provide informed consent
- Present in to ED
- BNP test requested
Who cannot join
- Males and females< 21 years
- Unable to provide informed consent
- Not presenting to ED
- hemolyzed sample
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland
Baltimore, Maryland, 21201
Henry Ford Health System
Detroit, Michigan, 48202
About this study
Official title: A Blood Collection From Patients Presenting in the Emergency Department and Prescribed a Brain Natriuretic Peptide (BNP) Laboratory Test
Plasma specimen collected from patients presenting in the Emergency Department (ED) with or without Heart Failure (HF) and prescribed a BNP.
Read the detailed description
Plasma samples are collected from a minimum of 400 subjects. Specimens are used to confirm the currently accepted BNP cut off as and aid in the diagnosis and assessment of HF.
Stored specimens for future use in BNP assay development.
- Conditions
- Heart Failure
- Being tested
- In Vitro diagnostic tests
- Keywords
- ED, BNP
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In Vitro diagnostic testsDevice
Also called Propective collection for use in InVitro diagnostic studies
Prospective blood collection
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure BNP
400 subjects
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2016
- Study completionAug 2016
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujirebio Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diana Dickson, RAC, Study director, Fujirebio Diagnostics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614209
- Sponsor's protocol ID
- FDI-120
- Acronym
- BNP
- Status last verified
- Nov 2015
- First submitted
- 6 Nov 2015
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blood Collection From Patients Presenting in the Emergency Department and Prescribed a Brain Natriuretic Peptide (BNP) Laboratory Test
- ClinicalTrials.gov ID
- NCT02614209
- Acronym / sponsor ID
- BNP / FDI-120
- Conditions
- Heart Failure
- Keywords
- ED, BNP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Fujirebio Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 25 Nov 2015 (estimated)
- 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.
Plasma specimen collected from patients presenting in the Emergency Department (ED) with or without Heart Failure (HF) and prescribed a BNP.
Detailed description
Plasma samples are collected from a minimum of 400 subjects. Specimens are used to confirm the currently accepted BNP cut off as and aid in the diagnosis and assessment of HF.
Stored specimens for future use in BNP assay development.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to ED and prescribed a BNP with or without HF
Key inclusion criteria (4 listed)
- Males and females >21 years of age
- Able to understand and willing to provide informed consent
- Present in to ED
- BNP test requested
Key exclusion criteria (4 listed)
- Males and females< 21 years
- Unable to provide informed consent
- Not presenting to ED
- hemolyzed sample
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 |
|---|---|---|
| In Vitro diagnostic testsAlso: Propective collection for use in InVitro diagnostic studiesProspective blood collection | Device | – |
Primary outcome
Measure BNP
Time frame: 6 months
400 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 10 Aug 2016.
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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.
Diana Dickson, RAC study director
Fujirebio Diagnostics, Inc.
2 sites 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 Fujirebio Diagnostics, Inc. at 2 sites in United States.
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 4 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 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Measure BNP (time frame: 6 months). 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 10 Aug 2016.