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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01028703

Enrollment

124

Registered

2009-12-09

Start date

2010-09-30

Completion date

2014-08-31

Last updated

2015-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

Chronic kidney disease, left ventricular dysfunction, diastolic dysfunction, hypertension

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United Kingdom

Outcome results