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ISRCTN
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ISRCTN25858715
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ClinicalTrials.gov identifier
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Public title
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The effects of Nocturnal Haemodialysis (NHD) compared to conventional haemodialysis on progression of Left Ventricular (LV) mass: a randomised controlled pilot study
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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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N/A
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Study hypothesis
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Nocturnal haemodialysis and conventional three times per week haemodialysis will not differ with respect to progression of LV mass (measured using Cardiac Magnetic Resonance [CMR]) at 6 months.
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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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Canada
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Disease/condition/study domain
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End-stage kidney disease
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Participants - inclusion criteria
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All adult haemodialysis patients in Alberta, Canada are eligible.
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Participants - exclusion criteria
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Patients who are unable to perform NHD due to physical or mental incapacity.
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Anticipated start date
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01/08/2004
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Anticipated end date
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30/06/2006
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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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38 subjects
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Interventions
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Subjects are randomised to nocturnal haemodialysis or conventional three times per week haemodialysis (controls).
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Primary outcome measure(s)
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Change in left ventricular mass (measured by CMR) at 6 months.
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Secondary outcome measure(s)
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1. Mean change in systolic Blood Pressure (BP)
2. Change in HRQOL (Health-Related Quality-Of-Life)
3. Mean change in Haematocrit (Hct)/Erythropoietin (Epo) ratio
4. Mean change in calcium - phosphorus product
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Sources of funding
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Kidney Foundation of Canada (Canada)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17878421
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Contact name
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Dr
Bruce
Culleton
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Address
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Foothills Hospital
1403-29th ST NW
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City/town
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Calgary
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Zip/Postcode
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T2N 2T9
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Country
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Canada
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Tel
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+1 403 944 8166
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Fax
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+1 403 270 0055
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Email
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bruce.culleton@calgaryhealthregion.ca
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Sponsor
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Kidney Foundation of Canada (Canada)
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Address
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300-5165 Sherbrooke ST W
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City/town
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Montreal, Quebec
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Zip/Postcode
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H4A 1T6
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Country
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Canada
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Email
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research@kidney.ca
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Sponsor website:
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http://www.kidney.ca/
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Date applied
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08/09/2004
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Last edited
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20/09/2007
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Date ISRCTN assigned
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19/10/2004
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