Cardiovascular Disease Clinical Trial
Official title:
The Cardiovascular Morbidity in Children With Chronic Renal Failure Study
Children and adolescents with chronic kidney disease (CKD) are at high risk for
cardiovascular (CV) morbidity and mortality. Recent studies suggest that pediatric patients
with even moderately impaired kidney function may be afflicted with significant early
cardiac and vascular abnormalities.
The pathogenesis and the natural course of CV comorbidity in pediatric CKD patients is still
elusive. In this multicenter, prospective, observational study the prevalence, degree and
progression of CV comorbidity in children will be characterized and related to CKD
progression. The morphology and function of the heart and vessels will be monitored by
sensitive, non-invasive methods and will be compared with aged matched healthy controls.
Multiple potential clinical, anthropometric, biochemical, and pharmacological risk factors
will be monitored prospectively and will be related to CV status. Genotyping might identify
predisposing genetic factors for progression of CV comorbidity and underlying nephropathies.
Adult patients with CKD are at markedly increased risk of dying from cardiovascular events.
The risk is most dramatically increased in young patients with end-stage renal disease, who
are almost as likely to die from cardiovascular causes as elderly individuals in the general
population.
Early morphological and functional vascular abnormalities can be detected even in
adolescents with CKD, but information about the prevalence, severity and natural course of
vascular lesions in different stages of renal failure is lacking and the factors
predisposing to an early onset and rapid progression of cardiovascular morbidity are still
elusive.
The pediatric population appears uniquely suited to study the effects of CKD on the
cardiovascular system due to the virtual absence of vascular morbidity related to ageing,
diabetes and smoking.
In order to improve our understanding of the causes and consequences of cardiovascular
comorbidity in children with progressive CKD, a consortium of pediatric nephrologists in
Europe has joined to perform a long-term prospective observational study following the
cardiovascular health of children as they advance through successive stages of CKD.
The 4C Study will follow up at least 625 patients aged 6 to 17 years with a glomerular
filtration rate of 10 to 45 ml/min/1.73 m² in more than 40 pediatric nephrology units in 14
European countries.
The morphology and function of the heart and the large arteries is regularly assessed by
sensitive, non-invasive methods and the findings compared to a large group of healthy
children.
Multiple potential clinical, anthropometric, biochemical, and pharmacological risk factors
are monitored prospectively and will be related to the cardiovascular status of the
patients.
A whole genome association study will be performed to identify genetic variants associated
with the progression of cardio-vascular alterations and renal failure.
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Observational Model: Cohort, Time Perspective: Prospective
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