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ISRCTN
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ISRCTN21944979
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ClinicalTrials.gov identifier
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Public title
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Identification of cardiac dysfunction in a GP outpatient setting using handheld echocardiography and brain natriuretic peptide (BNP) point of care testing
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Scientific title
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Diagnostic utility of point-of-care B-type-natriuretic peptide and handheld echocardiography in the primary care assessment of patients with suspected heart failure – the “Handheld-BNP”- Study, a four-arm randomised controlled trial
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Acronym
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Handheld-BNP-Study
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Serial number at source
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N/A
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Study hypothesis
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Use of handheld echocardiography and/or BNP point of care testing improves the rate of correct heart failure diagnoses in a GP outpatient setting.
Please note that the scientific title was added to this trial record as of 24/08/2009.
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Lay summary
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Ethics approval
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Approved by the Ethics Committee of the University of Würzburg and the State Ethics Committees of Bavaria and North Rhine Westfalia in 2004.
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Study design
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Four-arm diagnostic randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Heart failure diagnosis
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Participants - inclusion criteria
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1. Age >18 years
2. Written informed consent
3. A diagnosis of heart failure suspected by the GP solely on the grounds of history taking
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Participants - exclusion criteria
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Diagnosis of heart failure confirmed or excluded earlier.
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Anticipated start date
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01/03/2004
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Anticipated end date
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31/12/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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960
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Interventions
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This is a 4-arm diagnostic randomised study. GPs are trained and certified by experts to handle the diagnostic tools; each GP diagnoses a predefined number of patients with suspected heart failure using:
1. No additional tools
2. Handheld echocardiography
3. BNP point of care test
4. Handheld echocardiography and BNP test
GPs are randomly allocated 1:1:1:1 to the four diagnostic modalities. Within 14 days the diagnosis of the GP is verified or falsified by a cardiologist.
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Primary outcome measure(s)
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Concordance/discordance of diagnosis between GP and cardiologist.
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Secondary outcome measure(s)
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1. Agreement between BNP point of care test and BNP reference test at core lab
2. Time needed to train and certify GPs in the different diagnostic tools
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Sources of funding
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1. German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)
2. Philips Medizinsysteme Ultraschall (Germany)
3. Biosite Diagnostics GmbH (Germany)
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Trial website
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Publications
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Contact name
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Prof
Christiane E
Angermann
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Address
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Klinikstrasse 6-8
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City/town
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Wuerzburg
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Zip/Postcode
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97070
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Country
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Germany
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Tel
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+49 (0)931 201 70460
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Fax
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+49 (0)931 201 71240
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Email
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angermann_c@klinik.uni-wuerzburg.de
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Sponsor
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University of Wuerzburg (Germany)
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Address
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Sanderring 2
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City/town
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Wuerzburg
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Zip/Postcode
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97070
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Country
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Germany
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Tel
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+49 (0)931 31 2231
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Fax
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+49 (0)931 31 2100
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Email
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kanzler@zv.uni-wuerzburg.de
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Date applied
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21/09/2005
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Last edited
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24/08/2009
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Date ISRCTN assigned
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30/11/2005
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