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NCT05991089 Clinical Trial

Tunisian Clinical Registry on Chronic Kidney Disease in Hypertensive Patients

Hypertension Clinical Trial

— TUN-CKDH  

Official title:
Tunisian Clinical Registry on Chronic Kidney Disease in Hypertensive Patients. National Multicentric Cross Section Survey.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05991089
Other study ID # DAC-014-TUNCKDH
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 8, 2024
Est. completion date July 1, 2024

Study information
Verified date March 2024
Source Dacima Consulting
Contact Jannet Labidi, MD
Phone (+216)98902575
Email laabidi.jannet@yahoo.fr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility
Status Recruiting
Enrollment 10000
Est. completion date July 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Confirmed Hypertension - Follow-up at consultation at least for three months before enrollment date - Informed consent Exclusion Criteria: - Hypertension emergency - Pregnancy - Kidney transplanted subjects - Dialysis stage

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Tunisia Tunisian Society for Nephrology, Dialysis and Renal Transplantation Tunis

Sponsors (2)
Lead Sponsor Collaborator
Dacima Consulting Tunisian Society for Nephrology, Dialysis and Renal Transplantation

Country where clinical trial is conducted

Tunisia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of Chronic Kidney Disease Frequency of hypertensive subjects with chronic kidney disease At inclusion
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