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USE-BNP: Serial BNP Testing for Heart Failure Management

Sponsor
Siemens Healthcare Diagnostics Inc (Industry)
Overall Status
Terminated
CT.gov ID
NCT00622531
Collaborator
(none)
108
Enrollment
11
Locations
30
Duration (Months)
9.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: BNP assay (Siemens ADVIA Centaur BNP)
  • Other: hidden BNP value

Study Design

Study Type:
Observational
Actual Enrollment :
108 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Utilizing, Studying, Evaluating BNP for Monitoring in Patients With Heart Failure (USE-BNP)
Study Start Date :
Jan 1, 2007
Actual Primary Completion Date :
Jul 1, 2009
Actual Study Completion Date :
Jul 1, 2009

Arms and Interventions

Arm Intervention/Treatment
BNP Open

Subjects treated based on clinical assessment and knowledge of BNP values

Device: BNP assay (Siemens ADVIA Centaur BNP)
Diagnostic test
Other Names:
  • Siemens ADVIA Centaur BNP

    		•
    Control

    Subjects treated based on clinical assessment alone

    Other: hidden BNP value
    no intervention

    Outcome Measures

    Primary Outcome Measures

    1. composite endpoint of all cause mortality, hospitalization due to worsening heart failure and administration of IV drug therapy for worsening heart failure. [12 months]

    Secondary Outcome Measures

    1. NYHA classifications in the two treatment groups [12 months]

    2. Quality of life assessments of two treatment groups [12 months]

    3. change in therapy based on BNP usage [12 months]

    4. number of serious adverse events for the two groups [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Eligible subjects must be diagnosed with heart failure and have an abnormal BNP reading.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Palo Alto VA Health Care System Palo Alto California United States 94304
    2 Bellevue Hospital New York City New York United States 10016
    3 The Hudson Valley Heart Center Poughkeepsie New York United States 12601
    4 Wake Forest University Baptist Medical Center WInston-Salem North Carolina United States 27157
    5 UT Southwestern Medical Center Dallas Texas United States 75390
    6 Virginia Research Institute Danville Virginia United States 24541
    7 Centre Hospitalier Universitaire de Sherbrooke Fleurimont Quebec Canada J1H 5N4
    8 Centre Hospitalier de l'Université de Montréal (CHUM) Hôpital Hôtel Dieu Montreal Quebec Canada H2W 1T8
    9 McGill University Health Centre (MUHC) Royal Victoria Hospital Montreal Quebec Canada H3A 1A1
    10 McGill University Health Centre (MUHC) Montreal General Hospital Montreal Quebec Canada H3G 1A4
    11 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 de recherche du 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 Health Sciences
    • Principal Investigator: Eric Schaefer, MD, NYU Langone Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Siemens Healthcare Diagnostics Inc
    ClinicalTrials.gov Identifier:
    NCT00622531
    Other Study ID Numbers:
    • CTB-Centaur200603
    First Posted:
    Feb 25, 2008
    Last Update Posted:
    Nov 17, 2015
    Last Verified:
    Nov 1, 2015
    Keywords provided by Siemens Healthcare Diagnostics Inc
    heart failure
    BNP
    natriuretic peptide
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Nov 17, 2015