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ISRCTN
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ISRCTN06298974
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ClinicalTrials.gov identifier
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Public title
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Pilot Study to test the usefulness of contractile reserve during dobutamine and exercise echo to predict recovery after mitral valve repair mitral valve prolapse
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0019189543
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Study hypothesis
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To assess usefulness of contractile reserve during dobutamine and exercise echo to predict recovery after mitral valve repair for mitral valve prolapse. Whether contractile reserve judged by stress echocardiography, both pharmacological and exercise, can accurately predict post-operative exercise performance as judged by metabolic exercise performance following valve repair for mitral valve prolapse.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled pilot study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cardiovascular: Mitral valve disease
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Participants - inclusion criteria
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1. Patients admitted to Eastbourne District General Hospital for mitral valve repair
2. Accepted for repair of mitral valve prolapse on clinical grounds and high probability of repairable valve
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Participants - exclusion criteria
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1. Inability to perform test
2. Hypersensitivity to dobutamine or SonoView
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Anticipated start date
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07/03/2007
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Anticipated end date
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01/05/2007
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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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15
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Interventions
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Randomised Controlled Study
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Primary outcome measure(s)
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Death, myocardial infarction, hospitalisation for CHF.
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Secondary outcome measure(s)
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Baseline tissue Doppler contractile reserve, baseline exercise test parameters, neurohumoral markers, TOE and surgical parameters.
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Sources of funding
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East Sussex Hospitals NHS Trust
Peer Medical Research Trust
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Trial website
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Publications
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Contact name
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Dr
Guy
Lloyd
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Address
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Cardiology
Eastbourne District General Hospital
Kings Drive
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City/town
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Eastbourne
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Zip/Postcode
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BN21 2UD
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2007 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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28/09/2007
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Last edited
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22/10/2007
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Date ISRCTN assigned
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28/09/2007
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