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Predicting cardiovascular disease morbidity and mortality in chronic kidney disease in Spain. The rationale and design of NEFRONA: a prospective, multicenter, observational cohort study

DOI: 10.1186/1471-2369-11-14

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Abstract:

From November 2009 to October 2010, 4137 asymptomatic adult patients with stages 2 to 5 CKD will be recruited from nephrology services and dialysis units throughout Spain. During the same period, 843 participants without CKD (control group) will be recruited from lists of primary care physicians, only at baseline. During the follow-up, CVD events and mortality will be recorded from all CKD patients. Clinical and laboratory characteristics will be collected in a medical documentation sheet. Three trained itinerant teams will carry out a carotid ultrasound to assess intima-media thickness and presence of plaques. A composite atherosclerosis score will be constructed based on carotid ultrasound data and measurement of ankle-brachial index. In CKD patients, presence and type of calcifications will be assessed in the wall of carotid, femoral and brachial arteries, and in cardiac valves, by ultrasound. From all participants, blood samples will be collected and stored in a biobank to study novel biomarkers.The NEFRONA study is the first large, prospective study to examine the predictive value of several non-invasive imaging techniques and novel biomarkers in CKD patients throughout Spain. Hereby, we present the protocol of this study aimed to explore the most effective way in which these tests can be integrated with traditional risk factors to maximize CVD detection in this population.Cardiovascular disease (CVD) is the leading cause of cardiovascular morbidity and mortality in patients with chronic kidney disease (CKD) [1,2]. This association is even more evident in dialysis patients, where CV mortality accounts for 45% of all-cause mortality [3]. Therefore, as stated by the American Heart Association (AHA), CKD patients should be considered as CHD risk equivalent for risk factor management [4].Multivariable mathematical functions based on traditional cardiovascular risk factors, such as the Framingham Risk Score charts [5], have been developed for predicting CVD risk in

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