Clinical trial NCT01028703: Effects of a Reduction in Kidney Function on Cardiovascular Structure and Function: A Prospective Study of Kidney Donors
Official title: Does a Reduction in Renal Function Increase Arterial Stiffness and Left Ventricular Mass? - A Prospective Study of Kidney Donors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: Chronic kidney disease
left ventricular dysfunction
diastolic dysfunction
hypertension
Lead sponsor: University Hospital Birmingham NHS Foundation Trust
Sponsor class: OTHER
First posted: 2009-12-09
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Renal outpatient clinic

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


Eligibility criteria: 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.

Primary outcomes:
measure: Left ventricular mass as measured by CMR and Echocardiography
timeFrame: 3 years
measure: Arterial stiffness as measured by pulse wave velocity
timeFrame: 3 years
Secondary outcomes:
measure: Aortic compliance measured by cardiac magnetic resonance imaging
timeFrame: 3 years
measure: Left ventricular systolic and diastolic elastance measured by echocardiography;
timeFrame: 3 years
measure: 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).
timeFrame: 3 years
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham NHS Foundation Trust
state: West Midlands
Study officials:
affiliation: Univeristy Hospital Birmingham NHS Foundation Trust
name: Jonathan N Townend
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moody WE, Ferro CJ, Edwards NC, Chue CD, Lin EL, Taylor RJ, Cockwell P, Steeds RP, Townend JN; CRIB-Donor Study Investigators. Cardiovascular Effects of Unilateral Nephrectomy in Living Kidney Donors. Hypertension. 2016 Feb;67(2):368-77. doi: 10.1161/HYPERTENSIONAHA.115.06608.