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

This study has been terminated.
(Study terminated due to insufficient enrollment)
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Baptist Health
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
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 30, 2014