Tunisian Clinical Registry on Chronic Kidney Disease in Hypertensive Patients. National Multicentric Cross Section Survey.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Prevalence of Chronic Kidney Disease
研究概览
简要总结
In Tunisia, high blood pressure (HTN) is a public health problem whose prevalence varies from 28.7% to 34.7%. Hypertension can be both, cause and consequence of chronic kidney disease, and its prevalence is quite high in this population. It is both a risk factor for mortality and cardiovascular morbidity, but also a major cause of terminal chronic kidney disease becoming an additional public health concern.
Detecting and diagnosing chronic kidney in all hypertensives at an early stage remains a global public health challenge. A well-conducted treatment makes it possible to reach the blood pressure objective but also to reduce the risk of occurrence of a cardiovascular event and to slow the progression of chronic kidney disease.
In Tunisia, few data exists concerning the prevalence of chronic kidney disease in hypertensive subjects, thus limiting the development and elaboration of preventive measures. A national survey will thus be conducted by the "Kidney and Metabolic Diseases" Working Group under the aegis of the Tunisian Society of Nephrology, Dialysis and Kidney Transplantation. The main objective is to estimate the prevalence of chronic kidney disease in hypertensive tunisian patients.
详细描述
This is national multicentric cross-sectional survey. The study will be carried out for one month at medical departments and ambulatory clinics of general physicians, family medicine specialists, endocrinologists, specialists in nutrition and metabolic diseases, nephrologists, internal medicine physicians, cardiologists, all physicians caring for non-diabetic hypertensive patients or any healthcare providers in charge of hypertensive patients.
A Steering Committee helps investigators to monitor their patient inclusions, performs audit trails and prepares the statistical analysis plan for the study. Collected data are managed by the DACIMA Clinical Suite®, the electronic data capture platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed Hypertension
- •Follow-up at consultation at least for three months before enrollment date
- •Informed consent
排除标准
- •Hypertension emergency
- •Pregnancy
- •Kidney transplanted subjects
- •Dialysis stage
结局指标
主要结局
Prevalence of Chronic Kidney Disease
时间窗: At inclusion
Frequency of hypertensive subjects with chronic kidney disease
次要结局
未报告次要终点
