Congestive Heart Failure (CHF)WB-13NCT00734045
Prospective Evaluation of the StatusFirst™ CHF NT-proBNP Device in Human Whole Blood and Plasma Samples
An observational study of Congestive Heart Failure (CHF), run by Nanogen, Inc. at 2 sites in United States.
Trial summary
The primary objective of the study is to establish the correlation between NT-proBNP measurements in fresh human whole blood samples and those in plasma samples from the same study subjects, where said samples are collected in EDTA and Li-Hep anticoagulant tubes and measured by the StatusFirst™ CHF NT-proBNP device in… Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Congestive Heart Failure (CHF)
- How many people
- 450 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2008to Nov 2008
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients to be recruited for the study should either: * have clinically confirmed heart failure (NYHA class I-IV) or have presented to an emergency room or clinic with signs, symptoms and/or risk factors suggestive of heart failure, OR * be non-CHF controls greater than 45 years of age with no history of heart failure or cardiovascular disease.
Who may be able to join
- Have clinically confirmed heart failure (NYHA class I-IV) or have presented to an emergency room or clinic with signs, symptoms and/or risk factors suggestive of heart failure, OR
- Be non-CHF controls greater than 45 years of age with no history of heart failure or cardiovascular disease.
Who cannot join
- Be 45 years of age or younger
Trial locations and contacts
2 sites in 1 country.
United States2 sites
US Department of Veteran's Affairs
San Diego, California, 92161
San Francisco General Hospital
San Francisco, California, 94110
About this study
The primary objective of the study is to establish the correlation between NT-proBNP measurements in fresh human whole blood samples and those in plasma samples from the same study subjects, where said samples are collected in EDTA and Li-Hep anticoagulant tubes and measured by the StatusFirst™ CHF NT-proBNP device in conjunction with the DXpressTM Reader in a laboratory setting.
- Conditions
- Congestive Heart Failure (CHF)
- Keywords
- Congestive Heart Failure (CHF), NT-proBNP
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Subjects with diagnosed congestive heart failure | |
| 2 | Subjects not diagnosed with congestive heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
StatusFirst CHF NT-proBNP test result
Measured: At presentation to study site (no follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study startFeb 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart Failure (CHF)Studies 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
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanogen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alan Wu, PhD, Principal investigator, University of California San Francisco and San Francisco General HospitalAlan Maisel, MD, Principal investigator, University of California San Diego; Veteran's Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734045
- Sponsor's protocol ID
- WB-13
- Acronym
- WB-13
- Status last verified
- Dec 2008
- First submitted
- 11 Aug 2008
- Last updated
- 10 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the StatusFirst™ CHF NT-proBNP Device in Human Whole Blood and Plasma Samples
- ClinicalTrials.gov ID
- NCT00734045
- Acronym / sponsor ID
- WB-13 / WB-13
- Conditions
- Congestive Heart Failure (CHF)
- Keywords
- Congestive Heart Failure (CHF), NT-proBNP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Nanogen, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 13 Aug 2008 (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.
The primary objective of the study is to establish the correlation between NT-proBNP measurements in fresh human whole blood samples and those in plasma samples from the same study subjects, where said samples are collected in EDTA and Li-Hep anticoagulant tubes and measured by the StatusFirst™ CHF NT-proBNP device in conjunction with the DXpressTM Reader in a laboratory setting.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Subjects with diagnosed congestive heart failure |
| 2 | – | –Subjects not diagnosed with congestive heart failure |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients to be recruited for the study should either: * have clinically confirmed heart failure (NYHA class I-IV) or have presented to an emergency room or clinic with signs, symptoms and/or risk factors suggestive of heart failure, OR * be non-CHF controls greater than 45 years of age with no history of heart failure or cardiovascular disease.
Key inclusion criteria (2 listed)
- Have clinically confirmed heart failure (NYHA class I-IV) or have presented to an emergency room or clinic with signs, symptoms and/or risk factors suggestive of heart failure, OR
- Be non-CHF controls greater than 45 years of age with no history of heart failure or cardiovascular disease.
Key exclusion criteria (1 listed)
- Be 45 years of age or younger
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
StatusFirst CHF NT-proBNP test result
Time frame: At presentation to study site (no follow-up)
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 Dec 2008.
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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.
Alan Wu, PhD principal investigator
University of California San Francisco and San Francisco General Hospital
Alan Maisel, MD principal investigator
University of California San Diego; Veteran's Affairs
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 Congestive Heart Failure (CHF), run by Nanogen, 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 2 inclusion and 1 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 Dec 2008. 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?
StatusFirst CHF NT-proBNP test result (time frame: At presentation to study site (no follow-up)). 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 Dec 2008.