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

Completed

• Conditions: Chronic Kidney Disease

• Registration Number: NCT01028703
• Lead Sponsor: University Hospital Birmingham NHS Foundation Trust

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 available

Study Timeline

• Study First Submitted: 2009-12-08
• Study First Submitted QC: 2009-12-08
• Study First Posted: 2009-12-09
• Study Start: 2010-09
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-02
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Left ventricular mass as measured by CMR and Echocardiography	3 years
Arterial stiffness as measured by pulse wave velocity	3 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Birmingham NHS Foundation Trust; 🇬🇧 Birmingham, West Midlands, United Kingdom