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.
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Cairo
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Egypt, Cairo, Egipto
- Research Site
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Otro
- Perspectivas temporales: Transversal
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
To insert number of hypertensive patients with SBP that are reaching treatment goals
Periodo de tiempo: 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.
|
12 weeks +- 2
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Insert number of patients on antihypertensive pharmacological treatment reaching the DBP goals
Periodo de tiempo: 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.
|
12 +- 2 weeks
|
|
Insert number of patients on antihypertensive pharmacological treatment reaching SBP goals
Periodo de tiempo: 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.
|
12 +- 2 weeks
|
|
Insert epidemiological information on antihypertensive patients in study
Periodo de tiempo: 12 +- 2 weeks
|
|
12 +- 2 weeks
|
|
Insert treatment & managing plan of antihypertensive pharmacological treatment
Periodo de tiempo: 12 +- 2 weeks
|
|
12 +- 2 weeks
|
|
Insert number of patients on antihypertensive pharmacological treatment reaching DBP goals
Periodo de tiempo: 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
|
12+- 2 weeks
|
|
Insert epidemiological information on antihypertensive patients in study
Periodo de tiempo: 12 +- 2 weeks
|
|
12 +- 2 weeks
|
|
Insert epidemiological information on antihypertensive patients in study
Periodo de tiempo: 12 +- 2 weeks
|
|
12 +- 2 weeks
|
|
Insert treatment & managing plan of antihypertensive pharmacological treatment
Periodo de tiempo: 12 +- 2 weeks
|
|
12 +- 2 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mohamed A. Saleh, PHD, Proffessor Cardiology Ain Shams University
- Investigador principal: Mohamed Mohsen Ibrahim, PHD, Cairo University
- Investigador principal: Mohamed Awad Taher, PHD, Ain Shams University
- Investigador principal: Khaled Leon, PHD, National Heart Institute
- Investigador principal: Ahmed Shawky, PHD, Ain Shams University
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- D1843R00249
Información sobre medicamentos y dispositivos, documentos del estudio
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