Role of Depression in Blood Pressure Control. Study

Hypertension Clinical Trial

— TUN-BP-BLUE  

Official title:

Role of Depression in Blood Pressure Control. A Cross-sectional Multicentric Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05516173
• Other study ID #: santémilitaire10
• Status: Recruiting
• Start date: August 15, 2022
• Est. completion date: January 15, 2023

Study information

• Verified date: August 2022
• Source: General Administration of Military Health, Tunisia
• Contact: Aymen NOAMEN, MD
• Phone: +21620215773
• Email: no.aymen[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Our study aims to evaluate the role of depression in blood pressure control in ambulatory hypertensive patients.

Description:

Research Problem: Hypertension is a multifactorial disease that affects approximately one quarter of the adult population. It is a major risk factor for stroke and cardiovascular disease.

Environmental and psychosocial factors play an important role in hypertension onset and control. The prevalence of depression among hypertensive patients is 26, 8% and its presence is associated with increased risk of cardiovascular-related morbi-mortality. Our study aims to evaluate the role of depression in blood pressure control in ambulatory hypertensive patients. Investigative process: This study is a cross-sectional, multicentric and descriptive study. the investigators intend to include three hundred and two patients. After obtaining their consent, a 24 hour ambulatory blood pressure monitor will be used to evaluate blood pressure control.

Depression was assessed by the 9-item-Patient Health Questionnaire (PHQ-9) in Tunisian dialect. Clinical, socio-environmental, psychosocial and therapeutic and prognosis data will be collected from medical records.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 302
• Est. completion date: January 15, 2023
• Est. primary completion date: November 15, 2022
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients consulting for high blood pressure

• Patients older than 18 years.

• Patients able to give informed consent.

Non inclusion Criteria :

• Patients followed for depression under treatment.

• Hospitalized patients

Exclusion Criteria:

• a white coat hypertension

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Hypertension

Intervention

Diagnostic Test:
• Blood Pressure Monitoring, Ambulatory
To monitor the blood pressure during 24 hours.

Locations

Country	Name	City	State
Tunisia	Regional hospital of Ben Arous	Ben Arous
Tunisia	Interior Security Forces Hospital	La Marsa	Tunis
Tunisia	Tahar Sfar regional hospital of Mahdia	Mahdia
Tunisia	Military Hospital of Tunis	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
General Administration of Military Health, Tunisia

Country where clinical trial is conducted

Tunisia, 

References & Publications (1)

Li Z, Li Y, Chen L, Chen P, Hu Y. Prevalence of Depression in Patients With Hypertension: A Systematic Review and Meta-Analysis. Medicine (Baltimore). 2015 Aug;94(31):e1317. doi: 10.1097/MD.0000000000001317. Review. Erratum in: Medicine (Baltimore). 2018 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of depression in uncontrolled hypertensive patients.	The prevalence of depression evaluated by PHQ9 in Tunisian dialect in hypertensive patients with abnormal ambulatory 24 hours blood pressure monitoring	on inclusion