Chronic Kidney Disease: Determinants of Progression and Cardiovascular Risk

Study Overview
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Brief Summary
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Chronic kidney disease has become an important Public Health issue in most developed and developing countries, with increasing incidence and prevalence rates. The cost associated with chronic kidney disease patients is very high, derived from renal replacement therapy and the cost associated with the high cardiovascular risk of this population. Primary and secondary preventive measures are imperative. In this sense, the comprehension of mechanisms and biomarkers associated with CKD progression and mortality risk in this population is an important area of research. Cohort studies are important tools for testing risk factors and biomarkers. Currently, CKD cohorts, particularly of those not on dialysis, are few and restricted to North America and Europe. The present study established a cohort of 454 CKD participants (not on dialysis) in Sao Paulo, Brazil, who will be followed for 7-10 years. Baseline data collection was wide, including medical history, diet (food frequency questionnaire), calcium score, echocardiography, pulse wave velocity, cardiac frequency variability, carotid intimal media thickness, retinography, and an extensive biobank. Follow-up is ongoing and made through annual telephone interviews including questions on death, hospitalizations, and need of renal replacement therapy (RRT). Vital status is investigated periodically by a hot-pursuit strategy.

Official Title
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Chronic Kidney Disease: Determinants of Progression and Cardiovascular Risk. A Cohort Study in a Brazilian Population

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Other: CKD-related outcomes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients attending the outpatient service of Hospital das Clínicas, São Paulo, Brazil. ≥ 30 years. at least two measurements of creatinine (with a minimum interval of 3 months) ≥ 1.6 mg/dl for men and ≥ 1.4 mg/ dl for women. Exclusion Criteria: Patients attending oncology, psychiatry, human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), viral hepatitis and glomerulonephritis services were excluded. hospitalization within the last six months; acute myocardial infarction within the last six months; autoimmune diseases; current pregnancy; psychiatric diseases; ongoing chemotherapy or immunosuppressive therapy; current renal replacement therapy; HIV/AIDS infection; hepatitis B or C; any organ transplantation.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: CKD-related outcomes|the study is observational|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Mortality | Mortality of any cause, confirmed by official death certificates obtained through several health offices (PRO-AIM, Fundação SEADE and National Mortality Registry). | 7 years | 
| Renal replacement therapy | Initiation of any modality of renal replacement therapy, even if not permanently. Besides participant information, RRT will be ascertained through the city and state´s Registries (Sao Paulo State Registry of Dialysis and Transplantation, Sao Paulo City Registry of Dialysis and Transplantation). | 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic kidney disease, cardiovascular disease, mortality, end stage renal disease