CClinicalTrials.gg
Status unknownNCT03451929EPIRCEUpdated Mar 2, 2018

Kidney Function and Cardiovascular Events: Cohort Study in General Population

An observational study in Chronic Kidney Diseases, Progression and Cardiovascular Morbidity, sponsored by María Pilar Gayoso Diz. Status unknown. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-03-02.

Sponsored by María Pilar Gayoso Diz · Observational

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,746
Ages
20 Years to 90 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Chronic Kidney Diseases
  • Progression
  • Cardiovascular Morbidity

Keywords

  • primary healthcare
  • cohort
03

Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
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.

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:

  • Exclusion criteria: subjects that cannot be located or who refuse to give their consent to participate in this monitoring phase will be excluded.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,746 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
05

What researchers measure

Primary outcomes

  1. Impaired renal function

    50% reduction in the glomerular filtration rate with respect to the baseline

    Time frame: 2005-2018, up to 10 years

  2. mortality

    mortality due to cardiovascular problems or any others

    Time frame: 2005-2018, up to 10 years

  3. ACS

    acute coronary syndrome

    Time frame: 2005-2018, up to 10 years

  4. stroke

    ischemic, due to lack of blood flow, and hemorrhagic, due to bleeding.

    Time frame: 2005-2018, up to 10 years

Secondary outcomes

  1. health related quality of life

    SF-12

    Time frame: 2014-2018

  2. depression or anxiety

    Hospital Anxiety Depression Scale (HADS)

    Time frame: 2014-2018

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03451929
Lead sponsor
María Pilar Gayoso Diz
Responsible party
María Pilar Gayoso Diz (Family Medicine, PhD, Hospital Clinico Universitario de Santiago) — Sponsor-investigator
First posted
Mar 2, 2018
Start date
Jan 9, 2015
Primary completion
Jun 30, 2018 (estimated)
Completion
Dec 31, 2018 (estimated)
Last update
Mar 2, 2018

Study contacts

Pilar Gayoso-Diz, PhD
principal investigator · National Health Service of Spain

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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