Tunisian Clinical Registry on Chronic Kidney Disease in Hypertensive Patients

NCT ID: NCT05991089

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 11770 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-08
• Study Completion Date: 2024-07-01

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).

Conditions

Chronic Kidney Diseases; Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tunisian Society for Nephrology, Dialysis and Renal Transplantation

UNKNOWN

Sponsor Role: collaborator

Dacima Consulting

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jannet Labidi, MD

Role: STUDY_CHAIR

Military Hospital of Tunis (Tunis, Tunisia)

Amel Harzallah, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Charles Nicolle (Tunis, Tunisia)

Awatef Azzabi, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Sahloul (Sousse, Tunisia)

Badreddine Ben Kaab, MD

Role: PRINCIPAL_INVESTIGATOR

La Marsa Internal Security Forces Hospital (Tunis, Tunisia)

Ikram Mami, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of La Rabta (Tunis, Tunisia)

Lamia Rais, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of La Rabta (Tunis, Tunisia)

Maissa Hadji Brahim, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Taher Sfar (Mahdia, Tunisia)

Mouna Hammouda, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Fattouma Bourguiba (Monastir, Tunisia)

Sahar Agrebi, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Charles Nicolle (Tunis, Tunisia)

Seifeddine Azaiez, MD

Role: PRINCIPAL_INVESTIGATOR

Private Clinic (Ben Arous, Tunisia)

Soumaya Chargui, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Charles Nicolle (Tunis, Tunisia)

Locations

Tunisian Society for Nephrology, Dialysis and Renal Transplantation

Tunis, Tunisia, Tunisia

Countries

Tunisia

Other Identifiers

DAC-014-TUNCKDH

Identifier Type: -

Identifier Source: org_study_id