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

December 2, 2015 updated by: William E Moody, University Hospital Birmingham NHS Foundation Trust

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

124

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TT
        • University Hospital Birmingham NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Renal outpatient clinic

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Donors
110 will be "cases" that undergo uninephrectomy
Controls
110 "controls"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Left ventricular mass as measured by CMR and Echocardiography
Time Frame: 3 years
3 years
Arterial stiffness as measured by pulse wave velocity
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Aortic compliance measured by cardiac magnetic resonance imaging
Time Frame: 3 years
3 years
Left ventricular systolic and diastolic elastance measured by echocardiography;
Time Frame: 3 years
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Birmingham NHS Foundation Trust

Investigators

  • Principal Investigator: Jonathan N Townend, Univeristy Hospital Birmingham NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

December 8, 2009

First Submitted That Met QC Criteria

December 8, 2009

First Posted (Estimate)

December 9, 2009

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RKK3922

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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