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NCT Number: NCT02604771

Egypt Hypertension Study

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.

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Key information

Conditions

Different Classes of the Antihypertensive Treatment

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Egypt, Cairo Governorate

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. To insert number of hypertensive patients with SBP that are reaching treatment goals

    Time frame: 12 weeks +- 2

    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.

Secondary outcomes

  1. Insert number of patients on antihypertensive pharmacological treatment reaching the DBP goals

    Time frame: 12 +- 2 weeks

    Inserting number of SBP patients on antihypertensive treatment reaching the DBP goals according to the Europian Society of Cardiology (ESC) 2013 guidelines.

  2. Insert number of patients on antihypertensive pharmacological treatment reaching SBP goals

    Time frame: 12 +- 2 weeks

    Inserting number of patients on antihypertensive treatment reaching combined SBP &DBP treatment goals according to Europian Society of Cardiology (ESC) 2013 guidelines.

  3. Insert epidemiological information on antihypertensive patients in study

    Time frame: 12 +- 2 weeks

    • 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).

  4. Insert treatment & managing plan of antihypertensive pharmacological treatment

    Time frame: 12 +- 2 weeks

    • Investigator is to document the treatment/management with any changes in it chosen for the patient.
    • to document tolerability via questionnaire.

  5. Insert number of patients on antihypertensive pharmacological treatment reaching DBP goals

    Time frame: 12+- 2 weeks

    Inserting number of patients on antihypertensive treatment reaching combined SBP &DBP treatment goals according to Europian Society of Cardiology (ESC) 2013 guidelines

  6. Insert epidemiological information on antihypertensive patients in study

    Time frame: 12 +- 2 weeks

    • 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).

  7. Insert epidemiological information on antihypertensive patients in study

    Time frame: 12 +- 2 weeks

    • 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).

  8. Insert treatment & managing plan of antihypertensive pharmacological treatment

    Time frame: 12 +- 2 weeks

    • 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).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 13, 2015
Registry last updated
Nov 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.