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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01028703
• Other study ID #: RKK3922
• Status: Completed
• Phase: N/A
• First received: December 8, 2009
• Last updated: December 2, 2015
• Start date: September 2010
• Est. completion date: August 2014

Study information

• Verified date: December 2015
• Source: University Hospital Birmingham NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
United Kingdom	University Hospital Birmingham NHS Foundation Trust	Birmingham	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Birmingham NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular mass as measured by CMR and Echocardiography		3 years	No
Primary	Arterial stiffness as measured by pulse wave velocity		3 years	No
Secondary	Aortic compliance measured by cardiac magnetic resonance imaging		3 years	No
Secondary	Left ventricular systolic and diastolic elastance measured by echocardiography;		3 years	No
Secondary	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	No