Chronic Kidney Disease: Determinants of Progression and Cardiovascular Risk. A Cohort Study in a Brazilian Population
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
- 否
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
Silvia Maria de Oliveira Titan
Principal Investigator, MD-PhD
University of Sao Paulo
