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

Sponsor

University Hospital Birmingham NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT01028703

Collaborator

(none)

124

Enrollment

Location

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

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:

Increased arterial stiffness and left ventricular mass
Abnormalities in left ventricular systolic and diastolic function
Increased oxidative stress, inflammation and collagen turnover

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease

Study Design

Study Type:

Observational

Actual Enrollment :

124 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Donors 110 will be "cases" that undergo uninephrectomy
Controls 110 "controls"

Outcome Measures

Primary Outcome Measures

Left ventricular mass as measured by CMR and Echocardiography [3 years]
Arterial stiffness as measured by pulse wave velocity [3 years]

Secondary Outcome Measures

Aortic compliance measured by cardiac magnetic resonance imaging [3 years]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.