Kidney Function and Cardiovascular Events: Cohort Study in General Population

• Conditions: Chronic Kidney Diseases; Cardiovascular Morbidity; Progression

• Registration Number: NCT03451929
• Lead Sponsor: María Pilar Gayoso Diz

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.

Study Timeline

• Study Start: 2015-01-09
• Status Verified: 2018-02
• Study First Submitted: 2018-02-26
• Study First Submitted QC: 2018-02-26
• Last Update Submitted: 2018-02-26
• Study First Posted: 2018-03-02
• Last Update Posted: 2018-03-02
• Primary Completion: 2018-06-30
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2746

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mortality	2005-2018, up to 10 years	mortality due to cardiovascular problems or any others
stroke	2005-2018, up to 10 years	ischemic, due to lack of blood flow, and hemorrhagic, due to bleeding.
ACS	2005-2018, up to 10 years	acute coronary syndrome
Impaired renal function	2005-2018, up to 10 years	50% reduction in the glomerular filtration rate with respect to the baseline

Secondary Outcome Measures

Name	Time	Method
health related quality of life	2014-2018	SF-12
depression or anxiety	2014-2018	Hospital Anxiety Depression Scale (HADS)