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ISRCTN
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ISRCTN21486547
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ClinicalTrials.gov identifier
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Public title
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Immune activation in chronic heart failure and the role of endotoxin
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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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N0201082084
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Study hypothesis
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To investigate whether CHF is associated with immune dysregulation and to establish whether endotoxin levels are increased in heart failure patients and whether an endotoxin challenge is a component of immune activation in patients with severe CHF. Study could lead to new therapeutic insights and could contribute to the development of new therapeutic strategies for immune activation in CHF and a syndrome currently without effective treatment ie cardiac cachexia.
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Lay summary
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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 trial
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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: Chronic heart failure
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Participants - inclusion criteria
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Not provided at time of registration
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/04/1997
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Anticipated end date
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29/06/2006
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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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20
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Interventions
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Study A: Randomised Controlled Trial (10 cachetic and 10 non-cachetic stable CHF patients, and 10 controls)
Study B: Cohort Observation (10 CHF patients presenting acute oedematous exacerbation)
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Royal Brompton and Harefield NHS Trust (UK) Joint Committee for Research
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Trial website
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Publications
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Contact name
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Prof
Philip A
Poole-Wilson
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Address
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Imperial College School of Medicine NHLI
Guy Scadding Building
Dovehouse Street
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City/town
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London
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Zip/Postcode
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SW3 6LY
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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 - 2006 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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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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29/09/2006
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Last edited
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16/02/2010
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Date ISRCTN assigned
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29/09/2006
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