Heart FailureUSE-BNPNCT00622531
Serial BNP Testing for Heart Failure Management
An observational study of Heart Failure, run by Siemens Healthcare Diagnostics Inc at 11 sites in 2 countries.
Trial summary
The scope of the USE-BNP Trial is to investigate whether knowledge of BNP measurements, in conjunction with clinical assessment, in the outpatient setting can guide the management of therapy in patients with heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- BNP assay (Siemens ADVIA Centaur BNP) and hidden BNP value
- Type of treatment
- Medical device
- How many people
- 108 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Jan 2007to Jul 2009
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Cardiology or internal medicine clinics
Who may be able to join
- Eligible subjects must be diagnosed with heart failure and have an abnormal BNP reading.
Who cannot join
None listed.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States6 sites
UT Southwestern Medical Center
Dallas, Texas, 75390
Virginia Research Institute
Danville, Virginia, 24541
Bellevue Hospital
New York, New York, 10016
Palo Alto VA Health Care System
Palo Alto, California, 94304
The Hudson Valley Heart Center
Poughkeepsie, New York, 12601
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
Canada5 sites
Centre Hospitalier Universitaire de Sherbrooke
Fleurimont, Quebec, J1H 5N4
Centre Hospitalier de l'Université de Montréal (CHUM) Hôpital Hôtel Dieu
Montreal, Quebec, H2W 1T8
McGill University Health Centre (MUHC) Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
McGill University Health Centre (MUHC) Montreal General Hospital
Montreal, Quebec, H3G 1A4
Centre de santé et de services sociaux région de Thetford
Thetford-Mines, Quebec, G6G 2V4
About this study
Official title: Utilizing, Studying, Evaluating BNP for Monitoring in Patients With Heart Failure (USE-BNP)
The scope of the USE-BNP Trial is to investigate whether knowledge of BNP measurements, in conjunction with clinical assessment, in the outpatient setting can guide the management of therapy in patients with heart failure.
- Conditions
- Heart Failure
- Being tested
- BNP assay (Siemens ADVIA Centaur BNP), hidden BNP value
- Keywords
- heart failure, BNP, natriuretic peptide
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNP assay (Siemens ADVIA Centaur BNP)Device
Also called Siemens ADVIA Centaur BNP
Diagnostic test
hidden BNP valueOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| BNP Open | Subjects treated based on clinical assessment and knowledge of BNP values Receives: Device: BNP assay (Siemens ADVIA Centaur BNP) | |
| Control | Subjects treated based on clinical assessment alone Receives: Other: hidden BNP value |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite endpoint of all cause mortality, hospitalization due to worsening heart failure and administration of IV drug therapy for worsening heart failure.
Measured: 12 months
Secondary outcomes (4)
NYHA classifications in the two treatment groups
Measured: 12 months
Quality of life assessments of two treatment groups
Measured: 12 months
change in therapy based on BNP usage
Measured: 12 months
number of serious adverse events for the two groups
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startJan 2007
- Primary completionJul 2009
- Study completionJul 2009
Why it stopped: Study terminated due to insufficient enrollment
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siemens Healthcare Diagnostics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Denis C Phaneuf, MD, Principal investigator, Centre Hospitalier de l'Université de Montréal (CHUM) Hôpital Hôtel DieuSerge Lepage, MD, Principal investigator, Centre de recherche du Centre hospitalier universitaire de SherbrookeBoshara Zakhary, MD, Principal investigator, Virginia Research InstituteRobert Dupuis, MD, Principal investigator, Centre de santé et de services sociaux région de ThetfordLee Marcus, MD, Principal investigator, The Hudson Valley Heart CenterThao Huynh, MD, Principal investigator, McGill University Health Centre (MUHC) Montreal General HospitalNadia Giannetti, MD, Principal investigator, McGill University Health Centre (MUHC) Royal Victoria HospitalDavid Markham, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622531
- Sponsor's protocol ID
- CTB-Centaur200603
- Acronym
- USE-BNP
- Status last verified
- Nov 2015
- First submitted
- 14 Feb 2008
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing, Studying, Evaluating BNP for Monitoring in Patients With Heart Failure (USE-BNP)
- ClinicalTrials.gov ID
- NCT00622531
- Acronym / sponsor ID
- USE-BNP / CTB-Centaur200603
- Conditions
- Heart Failure
- Keywords
- heart failure, BNP, natriuretic peptide
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study terminated due to insufficient enrollment
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Siemens Healthcare Diagnostics IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 25 Feb 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 scope of the USE-BNP Trial is to investigate whether knowledge of BNP measurements, in conjunction with clinical assessment, in the outpatient setting can guide the management of therapy in patients with heart failure.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BNP Open | – | Device: BNP assay (Siemens ADVIA Centaur BNP)Subjects treated based on clinical assessment and knowledge of BNP values |
| Control | – | Other: hidden BNP valueSubjects treated based on clinical assessment alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiology or internal medicine clinics
Key inclusion criteria (1 listed)
- Eligible subjects must be diagnosed with heart failure and have an abnormal BNP reading.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| BNP assay (Siemens ADVIA Centaur BNP)Also: Siemens ADVIA Centaur BNPDiagnostic test | Device | BNP Open |
| hidden BNP valueno intervention | Other | Control |
Primary outcome
composite endpoint of all cause mortality, hospitalization due to worsening heart failure and administration of IV drug therapy for worsening heart failure.
Time frame: 12 months
4 secondary outcomes
NYHA classifications in the two treatment groups
Time frame: 12 months
Quality of life assessments of two treatment groups
Time frame: 12 months
change in therapy based on BNP usage
Time frame: 12 months
number of serious adverse events for the two groups
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Study terminated due to insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
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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.
Denis C Phaneuf, MD principal investigator
Centre Hospitalier de l'Université de Montréal (CHUM) Hôpital Hôtel Dieu
Serge Lepage, MD principal investigator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Boshara Zakhary, MD principal investigator
Virginia Research Institute
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Siemens Healthcare Diagnostics Inc at 11 sites in 2 countries.
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 1 inclusion and 0 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: stopped early, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Canada. 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 was stopped early (reason given: Study terminated due to insufficient enrollment). Results are not available in the source record.
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?
composite endpoint of all cause mortality, hospitalization due to worsening heart failure and administration of IV drug therapy for worsening heart failure. (time frame: 12 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 17 Nov 2015.