Kidney Function and Cardiovascular Events: Cohort Study in General Population (EPIRCE)

Kidney Function and Markers of Inflamation in Relation to Mortality, Cardiovascular Events and Kidney Function Impaired: Cohort Study in General Adult Population

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Kidney Diseases; Progression; Cardiovascular Morbidity

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 Type: Observational
• Enrollment (Actual): 2746

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
health related quality of life	SF-12	2014-2018
depression or anxiety	Hospital Anxiety Depression Scale (HADS)	2014-2018

Collaborators and Investigators

• Sponsor: María Pilar Gayoso Diz
• Investigators: Principal Investigator: Pilar Gayoso-Diz, PhD, National Health Service of Spain

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2015
• Primary Completion (Anticipated): June 30, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (Actual): March 2, 2018

Study Record Updates

• Last Update Posted (Actual): March 2, 2018
• Last Update Submitted That Met QC Criteria: February 26, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: cohort; primary healthcare
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: EPIRCE2; PI13/02031 (Other Grant/Funding Number: IS Carlos III)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO