Serial BNP Testing for Heart Failure Management (USE-BNP)

November 16, 2015 updated by: Siemens Healthcare Diagnostics Inc

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Fleurimont, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke
      • Montreal, Quebec, Canada, H2W 1T8
        • Centre Hospitalier de l'Université de Montréal (CHUM) Hôpital Hôtel Dieu
      • Montreal, Quebec, Canada, H3A 1A1
        • McGill University Health Centre (MUHC) Royal Victoria Hospital
      • Montreal, Quebec, Canada, H3G 1A4
        • McGill University Health Centre (MUHC) Montreal General Hospital
      • Thetford Mines, Quebec, Canada, G6G 2V4
        • Centre de santé et de services sociaux région de Thetford
  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Palo Alto VA Health Care System
    • New York
      • New York City, New York, United States, 10016
        • Bellevue Hospital
      • Poughkeepsie, New York, United States, 12601
        • The Hudson Valley Heart Center
    • North Carolina
      • WInston-Salem, North Carolina, United States, 27157
        • Wake Forest University Baptist Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
    • Virginia
      • Danville, Virginia, United States, 24541
        • Virginia Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cardiology or internal medicine clinics

Description

Inclusion Criteria:

  • Eligible subjects must be diagnosed with heart failure and have an abnormal BNP reading.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
NYHA classifications in the two treatment groups
Time Frame: 12 months
12 months
Quality of life assessments of two treatment groups
Time Frame: 12 months
12 months
change in therapy based on BNP usage
Time Frame: 12 months
12 months
number of serious adverse events for the two groups
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

February 14, 2008

First Submitted That Met QC Criteria

February 22, 2008

First Posted (Estimate)

February 25, 2008

Study Record Updates

Last Update Posted (Estimate)

November 17, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTB-Centaur200603

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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