Serial BNP Testing for Heart Failure Management

Heart Failure Clinical Trial

— USE-BNP  

Official title:

Utilizing, Studying, Evaluating BNP for Monitoring in Patients With Heart Failure (USE-BNP)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00622531
• Other study ID #: CTB-Centaur200603
• Status: Terminated
• Phase: N/A
• First received: February 14, 2008
• Last updated: November 16, 2015
• Start date: January 2007
• Est. completion date: July 2009

Study information

• Verified date: November 2015
• Source: Siemens Healthcare Diagnostics Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardCanada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 108
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• BNP assay (Siemens ADVIA Centaur BNP)
Diagnostic test

Other:
• hidden BNP value
no intervention

Locations

Country	Name	City	State
Canada	Centre Hospitalier Universitaire de Sherbrooke	Fleurimont	Quebec
Canada	Centre Hospitalier de l'Université de Montréal (CHUM) Hôpital Hôtel Dieu	Montreal	Quebec
Canada	McGill University Health Centre (MUHC) Montreal General Hospital	Montreal	Quebec
Canada	McGill University Health Centre (MUHC) Royal Victoria Hospital	Montreal	Quebec
Canada	Centre de santé et de services sociaux région de Thetford	Thetford Mines	Quebec
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Virginia Research Institute	Danville	Virginia
United States	Bellevue Hospital	New York City	New York
United States	Palo Alto VA Health Care System	Palo Alto	California
United States	The Hudson Valley Heart Center	Poughkeepsie	New York
United States	Wake Forest University Baptist Medical Center	WInston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Siemens Healthcare Diagnostics Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite endpoint of all cause mortality, hospitalization due to worsening heart failure and administration of IV drug therapy for worsening heart failure.		12 months	No
Secondary	NYHA classifications in the two treatment groups		12 months	No
Secondary	Quality of life assessments of two treatment groups		12 months	No
Secondary	change in therapy based on BNP usage		12 months	No
Secondary	number of serious adverse events for the two groups		12 months	Yes