TUN-CKDH: Tunisian Clinical Registry on Chronic Disease in Hypertensive Patients.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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).
Study Design
Outcome Measures
Primary Outcome Measures
- Prevalence of Chronic Kidney Disease [At inclusion]
Frequency of hypertensive subjects with chronic kidney disease
Eligibility Criteria
Criteria
Inclusion Criteria:
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Confirmed Hypertension
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Follow-up at consultation at least for three months before enrollment date
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Informed consent
Exclusion Criteria:
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Hypertension emergency
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Pregnancy
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Kidney transplanted subjects
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Dialysis stage
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tunisian Society for Nephrology, Dialysis and Renal Transplantation | Tunis | Tunisia | 1000 |
Sponsors and Collaborators
- Dacima Consulting
- Tunisian Society for Nephrology, Dialysis and Renal Transplantation
Investigators
- Study Chair: Jannet Labidi, MD, Military Hospital of Tunis (Tunis, Tunisia)
- Principal Investigator: Amel Harzallah, MD, University Hospital of Charles Nicolle (Tunis, Tunisia)
- Principal Investigator: Awatef Azzabi, MD, University Hospital of Sahloul (Sousse, Tunisia)
- Principal Investigator: Badreddine Ben Kaab, MD, La Marsa Internal Security Forces Hospital (Tunis, Tunisia)
- Principal Investigator: Ikram Mami, MD, University Hospital of La Rabta (Tunis, Tunisia)
- Principal Investigator: Lamia Rais, MD, University Hospital of La Rabta (Tunis, Tunisia)
- Principal Investigator: Maissa Hadji Brahim, MD, University Hospital of Taher Sfar (Mahdia, Tunisia)
- Principal Investigator: Mouna Hammouda, MD, University Hospital of Fattouma Bourguiba (Monastir, Tunisia)
- Principal Investigator: Sahar Agrebi, MD, University Hospital of Charles Nicolle (Tunis, Tunisia)
- Principal Investigator: Seifeddine Azaiez, MD, Private Clinic (Ben Arous, Tunisia)
- Principal Investigator: Soumaya Chargui, MD, University Hospital of Charles Nicolle (Tunis, Tunisia)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DAC-014-TUNCKDH