Serial BNP Testing for Heart Failure Management - Full Text View

Sponsored by:	Siemens Healthcare Diagnostics Inc
Information provided by:	Siemens Healthcare Diagnostics Inc
ClinicalTrials.gov Identifier:	NCT00622531

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

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Utilizing, Studying, Evaluating BNP for Monitoring in Patients With Heart Failure (USE-BNP)

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

Biospecimen Description:

plasma

Estimated Enrollment:	800
Study Start Date:	January 2007
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 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
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

Contacts

Contact: Normand Despres, PhD	914-524-2680	normand.despres@siemens.com
Contact: Henry Mindicino, MS	914-524-2029	henry.mindicino@siemen.com

Locations

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

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

Responsible Party:	Siemens Healthcare Diagnostics ( Normand Despres, Head Clinical Affairs )
Study ID Numbers:	CTB-Centaur200603
Study First Received:	February 14, 2008
Last Updated:	February 22, 2008
ClinicalTrials.gov Identifier:	NCT00622531
Health Authority:	United States: Institutional Review Board; Canada: Health Canada

Keywords provided by Siemens Healthcare Diagnostics Inc:

heart failure
BNP
natriuretic peptide

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009