Clinical trial NCT00622531: Serial BNP Testing for Heart Failure Management
Official title: Utilizing, Studying, Evaluating BNP for Monitoring in Patients With Heart Failure (USE-BNP)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure
Keywords: heart failure
BNP
natriuretic peptide
Lead sponsor: Siemens Healthcare Diagnostics Inc
Sponsor class: INDUSTRY
First posted: 2008-02-25
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cardiology or internal medicine clinics

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.


Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: composite endpoint of all cause mortality, hospitalization due to worsening heart failure and administration of IV drug therapy for worsening heart failure.
timeFrame: 12 months
Secondary outcomes:
measure: NYHA classifications in the two treatment groups
timeFrame: 12 months
measure: Quality of life assessments of two treatment groups
timeFrame: 12 months
measure: change in therapy based on BNP usage
timeFrame: 12 months
measure: number of serious adverse events for the two groups
timeFrame: 12 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto VA Health Care System
state: California
city: New York City
country: United States
facility: Bellevue Hospital
state: New York
city: Poughkeepsie
country: United States
facility: The Hudson Valley Heart Center
state: New York
city: WInston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Danville
country: United States
facility: Virginia Research Institute
state: Virginia
city: Fleurimont
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM) Hôpital Hôtel Dieu
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre (MUHC) Royal Victoria Hospital
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre (MUHC) Montreal General Hospital
state: Quebec
city: Thetford Mines
country: Canada
facility: Centre de santé et de services sociaux région de Thetford
state: Quebec
Study officials:
affiliation: Centre Hospitalier de l'Université de Montréal (CHUM) Hôpital Hôtel Dieu
name: Denis C Phaneuf, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Serge Lepage, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Research Institute
name: Boshara Zakhary, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre de santé et de services sociaux région de Thetford
name: Robert Dupuis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hudson Valley Heart Center
name: Lee Marcus, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Health Centre (MUHC) Montreal General Hospital
name: Thao Huynh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Health Centre (MUHC) Royal Victoria Hospital
name: Nadia Giannetti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UT Southwestern Medical Center
name: David Markham, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Palo Alto VA Health Care System
name: Paul Heidenreich
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: William Little, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Eric Schaefer, MD
role: PRINCIPAL_INVESTIGATOR
References: