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临床试验/NCT03393663
NCT03393663已完成不适用

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

University of Sao Paulo0 个研究点目标入组 454 人开始时间: 2012年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
454
主要终点
Renal replacement therapy

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Renal replacement therapy

时间窗: 7 years

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).

Overall Mortality

时间窗: 7 years

Mortality of any cause, confirmed by official death certificates obtained through several health offices (PRO-AIM, Fundação SEADE and National Mortality Registry).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Silvia Maria de Oliveira Titan

Principal Investigator, MD-PhD

University of Sao Paulo

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