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Clinical Trials/NCT01028703
NCT01028703
Completed
Not Applicable

Does a Reduction in Renal Function Increase Arterial Stiffness and Left Ventricular Mass? - A Prospective Study of Kidney Donors

University Hospital Birmingham NHS Foundation Trust1 site in 1 country124 target enrollmentSeptember 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Kidney Disease
Sponsor
University Hospital Birmingham NHS Foundation Trust
Enrollment
124
Locations
1
Primary Endpoint
Left ventricular mass as measured by CMR and Echocardiography
Status
Completed
Last Updated
10 years ago

Overview

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
Registry
clinicaltrials.gov
Start Date
September 2010
End Date
August 2014
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital Birmingham NHS Foundation Trust
Responsible Party
Principal Investigator
Principal Investigator

William E Moody

BHF Clinical Research Fellow

University Hospital Birmingham NHS Foundation Trust

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.

Outcomes

Primary Outcomes

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 Outcomes

  • Left ventricular systolic and diastolic elastance measured by echocardiography;(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).(3 years)
  • Aortic compliance measured by cardiac magnetic resonance imaging(3 years)

Study Sites (1)

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