Key result
ILERVAS trial evaluates if early screening for subclinical vascular and kidney disease reduces cardiovascular events.
Why the study?
Chronic kidney disease and atherosclerosis are interrelated diseases that increase cardiovascular morbidity and mortality, but the prevalence of subclinical disease and impact of early diagnosis are not well defined.
Does early diagnosis screening for subclinical vascular and kidney disease reduce cardiovascular morbidity and mortality in adults aged 45-70 with cardiovascular risk factors?
RCT (n=19,800)
Randomly selected
Yes
Does early diagnosis screening for subclinical vascular and kidney disease reduce cardiovascular morbidity and mortality in adults aged 45-70 with cardiovascular risk factors?
The ILERVAS project is a randomized intervention study designed to assess whether early screening for subclinical vascular and kidney disease improves cardiovascular outcomes in at-risk adults.
Large RCT will test screening for subclinical disease; leaves open whether it reduces CV events until results emerge.
Background and objectives Chronic kidney disease (CKD) and atherosclerosis are 2 interrelated diseases that increase the risk of cardiovascular morbidity and mortality. The objectives of the ILERVAS project are: (1) to determine the prevalence of subclinical arterial disease and hidden kidney disease; (2) to assess the impact of early diagnosis of both diseases on cardiovascular morbidity and mortality and also on the progression of CKD; (3) to have a platform of data and biological samples. Methods Randomised intervention study. From 2015 to 2017, 19,800 people (9900 in the intervention group and 9900 in the control group) aged between 45 and 70 years without previous history of cardiovascular disease and with at least one cardiovascular risk factor will be randomly selected from the primary health care centres across the province of Lleida. A team of experts will travel around in a mobile unit to carry out the following baseline tests on the intervention group: Artery ultrasound, (carotid, femoral, transcranial and abdominal aorta), ankle-brachial index, spirometry, determination of advanced glycation end products, dried blood spot and urine spot tests. Additionally, blood and urine samples will be collected and stored in the biobank to identify new biomarkers using omics studies. Participants will be followed up until 2025 for identification of cardiovascular events, treatment changes and changes in lifestyle. Conclusions The ILERVAS project will reveal the prevalence of subclinical vascular disease and hidden kidney disease, determine whether or not their early diagnosis brings health benefits and will also allow investigation of new risk factors.
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Betriu et al. (2016) conducted an RCT in Subclinical vascular disease and hidden kidney disease (n=19,800). Early diagnostic testing (artery ultrasound, ankle-brachial index, spirometry, blood/urine tests) vs. Control group was evaluated on Cardiovascular morbidity and mortality and progression of chronic kidney disease. The ILERVAS project is a randomized trial designed to assess whether early diagnosis of subclinical vascular and kidney disease reduces cardiovascular morbidity and mortality in 19,800 at-risk adults.
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