Kidney Function and Cardiovascular Events: Cohort Study in General Population

NCT ID: NCT03451929

Last Updated: 2018-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2746 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-09
• Study Completion Date: 2018-12-31

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.

Conditions

Chronic Kidney Diseases; Progression; Cardiovascular Morbidity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

María Pilar Gayoso Diz

OTHER

Sponsor Role: lead

Responsible Party

María Pilar Gayoso Diz

Family Medicine, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Pilar Gayoso-Diz, PhD

Role: PRINCIPAL_INVESTIGATOR

National Health Service of Spain

Other Identifiers

PI13/02031

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EPIRCE2

Identifier Type: -

Identifier Source: org_study_id