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History of Changes for Study: NCT01028703
Effects of Early Chronic Kidney Disease on Cardiovascular Risk
Latest version (submitted December 2, 2015) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 8, 2009 None (earliest Version on record)
2 December 1, 2010 Recruitment Status, Study Status, Groups and Interventions, Oversight, Study Identification and Contacts/Locations
3 December 2, 2015 Recruitment Status, Study Status, Sponsor/Collaborators, Contacts/Locations and Study Design
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Study NCT01028703
Submitted Date:  December 8, 2009 (v1)

Open or close this module Study Identification
Unique Protocol ID: RKK02051980
Brief Title: Effects of Early Chronic Kidney Disease on Cardiovascular Risk
Official Title: Does a Reduction in Renal Function Increase Arterial Stiffness and Left Ventricular Mass? - A Prospective Study of Kidney Donors
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2009
Overall Status: Not yet recruiting
Study Start: September 2010
Primary Completion: February 2014 [Anticipated]
Study Completion: February 2014 [Anticipated]
First Submitted: December 8, 2009
First Submitted that
Met QC Criteria:
December 8, 2009
First Posted: December 9, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 8, 2009
Last Update Posted: December 9, 2009 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University Hospital Birmingham NHS Foundation Trust
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary:

Studies of patients with established kidney disease, even when this is mild, appear to show that they are at high risk of heart failure, stroke and sudden cardiac death. This may be because kidney disease causes stiffening of the arteries in the body which means that the heart and brain are damaged by high blood pressure. By studying patients before and after the removal of a kidney (uni-nephrectomy) for transplantation the investigators will find out for the first time in man the effect of an isolated reduction in kidney function on the structure and function of the arteries and heart.

Hypotheses. An isolated reduction in GFR occuring after surgical uni-nephrectomy is associated with long term adverse cardiac and vascular effects which include:

  1. Increased arterial stiffness and left ventricular mass
  2. Abnormalities in left ventricular systolic and diastolic function
  3. Increased oxidative stress, inflammation and collagen turnover
Detailed Description:
Open or close this module Conditions
Conditions: Chronic Kidney Disease
Keywords: Chronic kidney disease
left ventricular dysfunction
diastolic dysfunction
hypertension
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Case-Control
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 120 [Anticipated]
Number of Groups/Cohorts 2
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Uninephrectomy
60 will be "cases" that undergo kidney donation
Controls
60 "controls"
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Left ventricular mass as measured by CMR and Echocardiography
[ Time Frame: 3 years ]

2. Arterial stiffness as measured by pulse wave velocity
[ Time Frame: 3 years ]

Secondary Outcome Measures:
1. Aortic compliance measured by cardiac magnetic resonance imaging
[ Time Frame: 3 years ]

2. Left ventricular systolic and diastolic elastance measured by echocardiography;
[ Time Frame: 3 years ]

3. 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 ]

Open or close this module Eligibility
Study Population: Renal outpatient clinic
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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.
Open or close this module Contacts/Locations
Study Officials: Jonathan N Townend
Principal Investigator
Univeristy Hospital Birmingham NHS Foundation Trust
Locations: United Kingdom, West Midlands
University Hospital Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom, B15 2TT
Contact:Contact: Jonathan N Townend, BSc (Hons) MBChB MD FRCP FESC +44 121 697 8476 john.townend@uhb.nhs.uk
Contact:Sub-Investigator: William E Moody, BMedSc MBChB MRCP
Contact:Principal Investigator: Jonathan N Townend, BSc MBChB MD FRCP FESC
Contact:Sub-Investigator: Richard P Steeds, MA MD FRCP
Contact:Sub-Investigator: Charles J Ferro, BSc MBChB FRCP MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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