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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01028703 |
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Date of registration:
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08/12/2009 |
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Primary sponsor: |
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Public title:
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Effects of a Reduction in Kidney Function on Cardiovascular Structure and Function: A Prospective Study of Kidney Donors
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Scientific title:
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Does a Reduction in Renal Function Increase Arterial Stiffness and Left Ventricular Mass? - A Prospective Study of Kidney Donors |
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Date of first enrolment:
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September 2010 |
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Target sample size:
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120 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01028703 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Jonathan N Townend, BSc (Hons) MBChB MD FRCP FESC |
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Address:
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Telephone:
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+44 121 697 8476 |
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Email:
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john.townend@uhb.nhs.uk |
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Affiliation:
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Name:
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Jonathan N Townend |
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Address:
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Telephone:
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Email:
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Affiliation:
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Univeristy Hospital Birmingham NHS Foundation Trust |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Potential kidney donor attending University Hospital Birmingham NHS Foundation Trust
Current nationally set Exclusion Criteria:
- Diabetes mellitus
- Atrial fibrillation
- Left ventricular dysfunction (ejection fraction <40% on transthoracic
echocardiography)
- History of cardiovascular or pulmonary disease
- Evidence of hypertensive end-organ damage.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Kidney Disease
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Primary Outcome(s)
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Arterial stiffness as measured by pulse wave velocity
[Time Frame: 3 years]
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Left ventricular mass as measured by CMR and Echocardiography
[Time Frame: 3 years]
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Secondary Outcome(s)
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Aortic compliance measured by cardiac magnetic resonance imaging
[Time Frame: 3 years]
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Left ventricular systolic and diastolic elastance measured by echocardiography;
[Time Frame: 3 years]
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Oxidative stress, inflammation and collagen turnover measured by blood assays of plasma renin, aldosterone, high sensitivity C-reactive protein (hsCRP), procollagen type III aminoterminal peptide (PIIINP) and C-telopeptide for type I collagen (CITP).
[Time Frame: 3 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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