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

Overview

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

Full Title of Study: “Does a Reduction in Renal Function Increase Arterial Stiffness and Left Ventricular Mass? – A Prospective Study of Kidney Donors”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2014

Arms, Groups and Cohorts

  • Donors
    • 110 will be “cases” that undergo uninephrectomy
  • Controls
    • 110 “controls”

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital Birmingham NHS Foundation Trust
  • Provider of Information About this Clinical Study
    • Principal Investigator: William E Moody, BHF Clinical Research Fellow – University Hospital Birmingham NHS Foundation Trust
  • Overall Official(s)
    • Jonathan N Townend, Principal Investigator, Univeristy Hospital Birmingham NHS Foundation Trust

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