Serial BNP Testing for Heart Failure Management (USE-BNP)
This study has been terminated.
(Study terminated due to insufficient enrollment)
Sponsor:
Siemens Healthcare Diagnostics Inc
Information provided by:
Siemens Healthcare Diagnostics Inc
ClinicalTrials.gov Identifier:
NCT00622531
First received: February 14, 2008
Last updated: October 15, 2009
Last verified: October 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Heart Failure |
Device: BNP assay (Siemens ADVIA Centaur BNP) Other: hidden BNP value |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Utilizing, Studying, Evaluating BNP for Monitoring in Patients With Heart Failure (USE-BNP) |
Resource links provided by NLM:
Further study details as provided by Siemens Healthcare Diagnostics Inc:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- NYHA classifications in the two treatment groups [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Quality of life assessments of two treatment groups [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- change in therapy based on BNP usage [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- number of serious adverse events for the two groups [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples Without DNA
plasma
| Enrollment: | 108 |
| Study Start Date: | January 2007 |
| Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
BNP Open
Subjects treated based on clinical assessment and knowledge of BNP values
|
Device: BNP assay (Siemens ADVIA Centaur BNP)
Diagnostic test
Other Name: Siemens ADVIA Centaur BNP
|
|
Control
Subjects treated based on clinical assessment alone
|
Other: hidden BNP value
no intervention
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Cardiology or internal medicine clinics
Criteria
Inclusion Criteria:
- Eligible subjects must be diagnosed with heart failure and have an abnormal BNP reading.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00622531
Locations
| United States, California | |
| Palo Alto VA Health Care System | |
| Palo Alto, California, United States, 94304 | |
| United States, New York | |
| Bellevue Hospital | |
| New York City, New York, United States, 10016 | |
| The Hudson Valley Heart Center | |
| Poughkeepsie, New York, United States, 12601 | |
| United States, North Carolina | |
| Wake Forest University Baptist Medical Center | |
| WInston-Salem, North Carolina, United States, 27157 | |
| United States, Texas | |
| UT Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
| United States, Virginia | |
| Virginia Research Institute | |
| Danville, Virginia, United States, 24541 | |
| Canada, Quebec | |
| Centre Hospitalier Universitaire de Sherbrooke | |
| Fleurimont, Quebec, Canada, J1H 5N4 | |
| Centre Hospitalier de l'Université de Montréal (CHUM) Hôpital Hôtel Dieu | |
| Montreal, Quebec, Canada, H2W 1T8 | |
| McGill University Health Centre (MUHC) Montreal General Hospital | |
| Montreal, Quebec, Canada, H3G 1A4 | |
| McGill University Health Centre (MUHC) Royal Victoria Hospital | |
| Montreal, Quebec, Canada, H3A 1A1 | |
| Centre de santé et de services sociaux région de Thetford | |
| Thetford Mines, Quebec, Canada, G6G 2V4 | |
Sponsors and Collaborators
Siemens Healthcare Diagnostics Inc
Investigators
| Principal Investigator: | Denis C Phaneuf, MD | Centre Hospitalier de l'Université de Montréal (CHUM) Hôpital Hôtel Dieu |
| Principal Investigator: | Serge Lepage, MD | Centre Hospitalier Universitaire de Sherbrooke |
| Principal Investigator: | Boshara Zakhary, MD | Virginia Research Institute |
| Principal Investigator: | Robert Dupuis, MD | Centre de santé et de services sociaux région de Thetford |
| Principal Investigator: | Lee Marcus, MD | The Hudson Valley Heart Center |
| Principal Investigator: | Thao Huynh, MD | McGill University Health Centre (MUHC) Montreal General Hospital |
| Principal Investigator: | Nadia Giannetti, MD | McGill University Health Centre (MUHC) Royal Victoria Hospital |
| Principal Investigator: | David Markham, MD | UT Southwestern Medical Center |
| Principal Investigator: | Paul Heidenreich | Palo Alto VA Health Care System |
| Principal Investigator: | William Little, MD | Wake Forest University Baptist Medical Center |
| Principal Investigator: | Eric Schaefer, MD | Bellevue Hospital |
More Information
No publications provided
| Responsible Party: | Normand Despres, Head Clinical Affairs, Siemens Healthcare Diagnostics |
| ClinicalTrials.gov Identifier: | NCT00622531 History of Changes |
| Other Study ID Numbers: | CTB-Centaur200603 |
| Study First Received: | February 14, 2008 |
| Last Updated: | October 15, 2009 |
| Health Authority: | United States: Institutional Review Board Canada: Health Canada |
Keywords provided by Siemens Healthcare Diagnostics Inc:
|
heart failure BNP natriuretic peptide |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013