Egypt Hypertension Study

An Epidemiological Study to Evaluate Standard Daily Practice in Managing Patients With Arterial Hypertension

This study is an epidemiological non-interventional trial that aims to evaluate standard daily practice in managing patients with arterial hypertension. The trial only records real-life clinical practice with no additional diagnostic or monitoring procedures.

The study is purposed to collect the following Egypt-specific epidemiology data on hypertension: demographic data, patients' characteristics, and patients' management/treatment in order to reach its rationale.

Study Overview

• Status: Completed
• Conditions: Different Classes of the Antihypertensive Treatment

Detailed Description

This study is aimed to evaluate response rate of the antihypertensive treatment with Thiazide Diuretics, calcium antagonist, Angiotensin Converting enzyme Inhibitor, Angiotensin II receptor blocker, and Beta Blocker in real life practice, and to collect the following Egypt-specific epidemiology data on hypertensive patients: demographic data, patents characteristics, and patients' management/treatment.

Approximately 300 sites will be participating (1 investigator per site; 300 investigators). Patients that are to be enrolled will either be newly diagnosed with hypertension, or on current antihypertensive treatment, compiling a total of 3000 patients (21 years, or older). The study will be conducted in two sequential phases; the first phase will include 150 sites from Cairo, Giza and Alexandria aiming to reach 1500 patients followed by a second phase which will include 150 sites from Delta and Upper Egypt aiming to reach 1500 patients. Epidemiological data collection will take place at a single visit and Laboratory Investigations will be requested in the first visit. Patients will be followed for 3 visits with the investigator. The investigator will complete a Patient Record Form (PRF) with the patient's data: demographics, history, current antihypertensive drug treatment/treatment changes, results of physical examination, blood pressure (SBP/DBP), heart rate.

• Study Type: Observational
• Enrollment (Actual): 1500

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Egypt, Cairo, Egypt
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will be collected from private care clinics.

Description

Inclusion Criteria:

• Males or female aged >21 years
• Subject population with newly diagnosed essential arterial hypertension
• Subject population with essential arterial hypertension currently receiving treatment with any of the following antihypertensive classes: a Thiazide Diuretics, calcium antagonist, Angiotensin Converting enzyme Inhibitor, Angiotensin II receptor blocker and Beta Blocker for at least 3 months.
• Females of childbearing potential must use a reliable method of contraception.
• Subject willing to give written informed consent

Exclusion Criteria:

• If participating in any clinical trial, the subject cannot take part in this study.
• Pregnancy and lactation.
• Patients not willing to give Informed Consent.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To insert number of hypertensive patients with SBP that are reaching treatment goals	To insert number of patients with Systolic Blood pressure reaching treatment goals according to the ESC 2013 criteria (Systolic blood pressure <140 mmHg* in patients) after being treated with anti-hypertensive medication/s for at least 3 months.	12 weeks +- 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insert number of patients on antihypertensive pharmacological treatment reaching the DBP goals	Inserting number of SBP patients on antihypertensive treatment reaching the DBP goals according to the Europian Society of Cardiology (ESC) 2013 guidelines.	12 +- 2 weeks
Insert number of patients on antihypertensive pharmacological treatment reaching SBP goals	Inserting number of patients on antihypertensive treatment reaching combined SBP &DBP treatment goals according to Europian Society of Cardiology (ESC) 2013 guidelines.	12 +- 2 weeks
Insert epidemiological information on antihypertensive patients in study	Documenting epidemiological data from the Hypertensive patients during the visit via the investigator asking them and documenting it (Age); Documenting any associated major cardiovascular co-morbid diseases by the investigator asking the patient or checking patient history then writing it down in Case Report Form (CRF).	12 +- 2 weeks
Insert treatment & managing plan of antihypertensive pharmacological treatment	Investigator is to document the treatment/management with any changes in it chosen for the patient.; to document tolerability via questionnaire.	12 +- 2 weeks
Insert number of patients on antihypertensive pharmacological treatment reaching DBP goals	Inserting number of patients on antihypertensive treatment reaching combined SBP &DBP treatment goals according to Europian Society of Cardiology (ESC) 2013 guidelines	12+- 2 weeks
Insert epidemiological information on antihypertensive patients in study	Documenting epidemiological data from the Hypertensive patients during the visit via the investigator asking them and documenting it (Weight); Documenting any associated major cardiovascular co-morbid diseases by the investigator asking the patient or checking patient history then writing it down in Case Report Form (CRF).	12 +- 2 weeks
Insert epidemiological information on antihypertensive patients in study	Documenting epidemiological data from the Hypertensive patients during the visit via the investigator asking them and documenting it (gender); Documenting any associated major cardiovascular co-morbid diseases by the investigator asking the patient or checking patient history then writing it down in Case Report Form (CRF).	12 +- 2 weeks
Insert treatment & managing plan of antihypertensive pharmacological treatment	Investigator is to document the treatment/management with any changes in it chosen for the patient.; to document stability of the patient in the Case report form (CRF).	12 +- 2 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Mohamed A. Saleh, PHD, Proffessor Cardiology Ain Shams University; Principal Investigator: Mohamed Mohsen Ibrahim, PHD, Cairo University; Principal Investigator: Mohamed Awad Taher, PHD, Ain Shams University; Principal Investigator: Khaled Leon, PHD, National Heart Institute; Principal Investigator: Ahmed Shawky, PHD, Ain Shams University

Publications and helpful links

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2016
• Primary Completion (Actual): February 14, 2018
• Study Completion (Actual): February 14, 2018

Study Registration Dates

• First Submitted: August 18, 2015
• First Submitted That Met QC Criteria: November 11, 2015
• First Posted (Estimate): November 13, 2015

Study Record Updates

• Last Update Posted (Actual): November 7, 2019
• Last Update Submitted That Met QC Criteria: November 6, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: D1843R00249

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No