Clinical trial NCT03451929: Kidney Function and Cardiovascular Events: Cohort Study in General Population
Official title: Kidney Function and Markers of Inflamation in Relation to Mortality, Cardiovascular Events and Kidney Function Impaired: Cohort Study in General Adult Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Diseases
Progression
Cardiovascular Morbidity
Keywords: primary healthcare
cohort
Lead sponsor: Hospital Clinico Universitario de Santiago
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 2746
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A random sample, stratified by age and sex, of the over 20 population, representative of the general adult Spanish population. The sample population was the 2001 Census (National Statistical Institute of Spain, INE).

Sample size: 2746 subjects studied in Phase I of the EPIRCE study are included. This sample size allows for a 1.17% accuracy rate for the estimate of a proportion (prevalence) in a maximum dispersion variable (p = q = 0.5) with a 95% confidence interval.

Brief summary: Prospective multicenter follow-up study of 10 years. Cohort established between 2005-2007 with stratified random sample of general population older than 20 years (Census 2001), N= 2746 subjects.

Detailed description: The aim of this study is to analyse the evolution of kidney function (KF) in the general Spanish population and its impact in terms of quality of life, survival and prognosis for relevant clinical events: mortality, major vascular events and end stage renal disease (ESRD), over a period of 10 years. This is in line with the research priorities highlighted by Kidney Disease: Improving Global Outcomes (KDIGO) 2012.

The study is a prospective multi-centre 10 year follow-up study. Cohort established in Phase I of the EPIRCE study conducted in 2005-2007; stratified random sample of the general population over age 20 (2001 Census), with 2746 subjects studied with complete baseline characterization: socio-demographic variables, lifestyle factors, vascular risk, morbidity, and RF. Cox proportional hazard additive predictors will be used to study the predictive value of renal function models. All models will be adjusted for socio-demographic factors and lifestyle. IDI and NRI will be used to determine whether the addition of KF improves the predictive ability of the existing scores. Decision curve analysis will be used to indicate different KF cut-off points take cost and benefit into account in the decision to treat or not treat.

This project addresses the predictive capacity of glomerular filtration and albuminuria on mortality and vascular events after a 10-year follow-up in the general population, with an analysis of potential improvement in predicting vascular mortality and/or major vascular events by incorporating renal function into existing scales. It also establishes associated serum DNA samples to a well phenotyped cohort for subsequent studies of gene expression and inflammatory markers on CKD. These results will therefore provide insight into the natural evolution of CKD and associated vascular risk.

Eligibility criteria: Inclusion Criteria:

* Subjects studied in Phase I of the EPIRCE study. Give their informed consent to participate in this phase of EPIRCE 2 study.

Exclusion Criteria:

* Exclusion criteria: subjects that cannot be located or who refuse to give their consent to participate in this monitoring phase will be excluded.

Primary outcomes:
measure: Impaired renal function
timeFrame: 2005-2018, up to 10 years
measure: mortality
timeFrame: 2005-2018, up to 10 years
measure: ACS
timeFrame: 2005-2018, up to 10 years
measure: stroke
timeFrame: 2005-2018, up to 10 years
Secondary outcomes:
measure: health related quality of life
timeFrame: 2014-2018
measure: depression or anxiety
timeFrame: 2014-2018
Other outcomes:
Locations:
Study officials:
affiliation: National Health Service of Spain
name: Pilar Gayoso-Diz, PhD
role: PRINCIPAL_INVESTIGATOR
References: