Kidney Function and Cardiovascular Events: Cohort Study in General Population

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03451929

Acronym

EPIRCE

Enrollment

2746

Registered

2018-03-02

Start date

2015-01-09

Completion date

2018-12-31

Last updated

2018-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Morbidity, Chronic Kidney Diseases, Progression

Keywords

primary healthcare, cohort

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 90 Years

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

Design outcomes

Primary

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

Secondary

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

Outcome results