Clinical trial NCT05991089: Tunisian Clinical Registry on Chronic Kidney Disease in Hypertensive Patients
Official title: Tunisian Clinical Registry on Chronic Kidney Disease in Hypertensive Patients. National Multicentric Cross Section Survey.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Hypertension
Lead sponsor: Dacima Consulting
Sponsor class: OTHER
Collaborators: name: Tunisian Society for Nephrology, Dialysis and Renal Transplantation
First posted: 2023-08-14
Enrollment: 11770
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All confirmed hypertensive patients at enrollment

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).

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of Chronic Kidney Disease
timeFrame: At inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Tunisian Society for Nephrology, Dialysis and Renal Transplantation
Study officials:
affiliation: Military Hospital of Tunis (Tunis, Tunisia)
name: Jannet Labidi, MD
role: STUDY_CHAIR
affiliation: University Hospital of Charles Nicolle (Tunis, Tunisia)
name: Amel Harzallah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Sahloul (Sousse, Tunisia)
name: Awatef Azzabi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: La Marsa Internal Security Forces Hospital (Tunis, Tunisia)
name: Badreddine Ben Kaab, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of La Rabta (Tunis, Tunisia)
name: Ikram Mami, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of La Rabta (Tunis, Tunisia)
name: Lamia Rais, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Taher Sfar (Mahdia, Tunisia)
name: Maissa Hadji Brahim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Fattouma Bourguiba (Monastir, Tunisia)
name: Mouna Hammouda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Charles Nicolle (Tunis, Tunisia)
name: Sahar Agrebi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Clinic (Ben Arous, Tunisia)
name: Seifeddine Azaiez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Charles Nicolle (Tunis, Tunisia)
name: Soumaya Chargui, MD
role: PRINCIPAL_INVESTIGATOR
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