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Effects of a Reduction in Kidney Function on Cardiovascular Structure and Function: A Prospective Study of Kidney Donors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01028703
Recruitment Status : Completed
First Posted : December 9, 2009
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
William E Moody, University Hospital Birmingham NHS Foundation Trust

Tracking Information
First Submitted Date December 8, 2009
First Posted Date December 9, 2009
Last Update Posted Date December 3, 2015
Study Start Date September 2010
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 8, 2009)
  • Left ventricular mass as measured by CMR and Echocardiography [ Time Frame: 3 years ]
  • Arterial stiffness as measured by pulse wave velocity [ Time Frame: 3 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 8, 2009)
  • Aortic compliance measured by cardiac magnetic resonance imaging [ Time Frame: 3 years ]
  • Left ventricular systolic and diastolic elastance measured by echocardiography; [ Time Frame: 3 years ]
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of a Reduction in Kidney Function on Cardiovascular Structure and Function: A Prospective Study of Kidney Donors
Official Title Does a Reduction in Renal Function Increase Arterial Stiffness and Left Ventricular Mass? - A Prospective Study of Kidney Donors
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 Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Renal outpatient clinic
Condition Chronic Kidney Disease
Intervention Not Provided
Study Groups/Cohorts
  • Donors
    110 will be "cases" that undergo uninephrectomy
  • Controls
    110 "controls"
Publications * Moody WE, Ferro CJ, Edwards NC, Chue CD, Lin EL, Taylor RJ, Cockwell P, Steeds RP, Townend JN; CRIB-Donor Study Investigators. Cardiovascular Effects of Unilateral Nephrectomy in Living Kidney Donors. Hypertension. 2016 Feb;67(2):368-77. doi: 10.1161/HYPERTENSIONAHA.115.06608.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 2, 2015)
124
Original Estimated Enrollment
 (submitted: December 8, 2009)
120
Actual Study Completion Date August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01028703
Other Study ID Numbers RKK3922
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party William E Moody, University Hospital Birmingham NHS Foundation Trust
Original Responsible Party Dr Jonathan N Townend, University of Birmingham NHS Foundation Trust
Current Study Sponsor University Hospital Birmingham NHS Foundation Trust
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Jonathan N Townend Univeristy Hospital Birmingham NHS Foundation Trust
PRS Account University Hospital Birmingham NHS Foundation Trust
Verification Date December 2015