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
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

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