Cardiovascular Diseases Clinical Trial
Official title:
The Leicester City and County Chronic Kidney Disease Study: An Observational Chronic Kidney Disease Cohort to Study Cardiovascular and Renal Outcomes in Multi-ethnicity Primary Care
Chronic kidney disease (CKD) is estimated to affect 6-8% of the adult population and is
independently associated with increased cardiovascular (CV) disease risk. This risk increases
as CKD advances both in relation to worsening glomerular filtration rate and development of
proteinuria. The overall cost of CKD to the NHS (National Health Service) in England has been
estimated as £1.45 billion per annum, or 1.3% of the NHS's total budget. This includes £175
million, or 13% of the CKD budget, annually spent in relation to 19,000 excess myocardial
infarctions and strokes related to CKD.
The epidemiology of CKD in primary care is poorly studied. This is particularly the case in
non-white populations who have an independent higher risk of progression to end stage renal
failure (requiring dialysis or transplantation), CV events and death.
Further, CV disease risk in CKD remains poorly described beyond simple risk stratification by
CKD stage. A recent systematic review identified some CKD-specific CV disease risk scores.
However, all the risk scores had significant methodological limitations, such as a lack of
external validation or the perception that they were not 'clinically useful'. The Leicester
City and County Chronic Kidney Disease (LCC-CKD) cohort will be created from anonymised GP
(general practice) records of individuals with CKD. We will aim to retrospectively create a
cohort with 5 years follow-up to the present day. In addition, a present day cohort will be
created to both aid research and provide data for practices and clinical commissioning groups
for quality improvement (QI) purposes. We will aim to include 30,000 individuals with CKD in
the cohort.
The principal objectives of the study are:
1. To study the natural history of CKD in a multi-ethnic primary care setting
2. To contribute to the creation of a risk prediction tool for heart attacks and strokes in
CKD
The risk prediction tool would more accurately stratify risk of CV events for individuals
with CKD. This would aid patients and clinicians in deciding on treatments aimed at reducing
the risk of future myocardial infarctions and strokes. Currently, individuals with CKD,
despite higher risk of CV disease, may not be receiving optimum treatment such as statins and
anti-hypertensive medications. Improved management of cardiovascular risk factors in CKD is
likely to see a reduction in CKD associated excess CV events and their associated costs,
including longer average duration of inpatient admissions.
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