Tunisian Clinical Registry on Chronic Kidney Disease in Hypertensive Patients
- Conditions
- HypertensionChronic Kidney Diseases
- Registration Number
- NCT05991089
- Lead Sponsor
- Dacima Consulting
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10000
- Confirmed Hypertension
- Follow-up at consultation at least for three months before enrollment date
- Informed consent
- Hypertension emergency
- Pregnancy
- Kidney transplanted subjects
- Dialysis stage
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of Chronic Kidney Disease At inclusion Frequency of hypertensive subjects with chronic kidney disease
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Tunisian Society for Nephrology, Dialysis and Renal Transplantation
🇹🇳Tunis, Tunisia