Kidney Function and Cardiovascular Events: Cohort Study in General Population

Chronic Kidney Diseases Clinical Trial

— EPIRCE  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03451929
• Other study ID #: EPIRCE2
• Secondary ID: PI13/02031
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 26, 2018
• Last updated: February 26, 2018
• Start date: January 9, 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2018
• Source: Hospital Clinico Universitario de Santiago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2746
• Est. completion date: December 31, 2018
• Est. primary completion date: June 30, 2018
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Morbidity
• Chronic Kidney Diseases
• Kidney Diseases
• Progression
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
María Pilar Gayoso Diz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impaired renal function	50% reduction in the glomerular filtration rate with respect to the baseline	2005-2018, up to 10 years
Primary	mortality	mortality due to cardiovascular problems or any others	2005-2018, up to 10 years
Primary	ACS	acute coronary syndrome	2005-2018, up to 10 years
Primary	stroke	ischemic, due to lack of blood flow, and hemorrhagic, due to bleeding.	2005-2018, up to 10 years
Secondary	health related quality of life	SF-12	2014-2018
Secondary	depression or anxiety	Hospital Anxiety Depression Scale (HADS)	2014-2018