Clinical trial NCT02604771: Egypt Hypertension Study
Official title: An Epidemiological Study to Evaluate Standard Daily Practice in Managing Patients With Arterial Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Different Classes of the Antihypertensive Treatment
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2015-11-13
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be collected from private care clinics.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To insert number of hypertensive patients with SBP that are reaching treatment goals
timeFrame: 12 weeks +- 2
Secondary outcomes:
measure: Insert number of patients on antihypertensive pharmacological treatment reaching the DBP goals
timeFrame: 12 +- 2 weeks
measure: Insert number of patients on antihypertensive pharmacological treatment reaching SBP goals
timeFrame: 12 +- 2 weeks
measure: Insert epidemiological information on antihypertensive patients in study
timeFrame: 12 +- 2 weeks
measure: Insert treatment & managing plan of antihypertensive pharmacological treatment
timeFrame: 12 +- 2 weeks
measure: Insert number of patients on antihypertensive pharmacological treatment reaching DBP goals
timeFrame: 12+- 2 weeks
measure: Insert epidemiological information on antihypertensive patients in study
timeFrame: 12 +- 2 weeks
measure: Insert epidemiological information on antihypertensive patients in study
timeFrame: 12 +- 2 weeks
measure: Insert treatment & managing plan of antihypertensive pharmacological treatment
timeFrame: 12 +- 2 weeks
Other outcomes:
Locations:
city: Egypt
country: Egypt
facility: Research Site
state: Cairo
Study officials:
affiliation: Proffessor Cardiology Ain Shams University
name: Mohamed A. Saleh, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Mohamed Mohsen Ibrahim, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University
name: Mohamed Awad Taher, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Heart Institute
name: Khaled Leon, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University
name: Ahmed Shawky, PHD
role: PRINCIPAL_INVESTIGATOR
References: