NCT00622531

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2007

Typical duration for all trials

Geographic Reach
2 countries

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 25, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

2.5 years

First QC Date

February 14, 2008

Last Update Submit

November 16, 2015

Conditions

Heart Failure

Keywords

heart failureBNPnatriuretic peptide

Outcome Measures

Primary Outcomes (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 Outcomes (4)

  • NYHA classifications in the two treatment groups

    12 months

  • Quality of life assessments of two treatment groups

    12 months

  • change in therapy based on BNP usage

    12 months

  • number of serious adverse events for the two groups

    12 months

Study Arms (2)

BNP Open

Subjects treated based on clinical assessment and knowledge of BNP values

Device: BNP assay (Siemens ADVIA Centaur BNP)

Control

Subjects treated based on clinical assessment alone

Other: hidden BNP value

Interventions

BNP assay (Siemens ADVIA Centaur BNP)DEVICE

Diagnostic test

Also known as: Siemens ADVIA Centaur BNP
BNP Open
hidden BNP valueOTHER

no intervention

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cardiology or internal medicine clinics

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Palo Alto VA Health Care System

Palo Alto, California, 94304, United States

Location

Bellevue Hospital

New York, New York, 10016, United States

Location

The Hudson Valley Heart Center

Poughkeepsie, New York, 12601, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Virginia Research Institute

Danville, Virginia, 24541, United States

Location

Centre Hospitalier Universitaire de Sherbrooke

Fleurimont, Quebec, J1H 5N4, Canada

Location

Centre Hospitalier de l'Université de Montréal (CHUM) Hôpital Hôtel Dieu

Montreal, Quebec, H2W 1T8, Canada

Location

McGill University Health Centre (MUHC) Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

McGill University Health Centre (MUHC) Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Centre de santé et de services sociaux région de Thetford

Thetford-Mines, Quebec, G6G 2V4, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • 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

    University of Texas 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2008

First Posted

February 25, 2008

Study Start

January 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

US(6)CA(5)