Clinical trial NCT03607812: Diagnosis and Management of Arterial Hypertension for Algerian Patients in Current Medical Practice
Official title: ABPM (Automatic Measurement of Blood Pressure) Evaluation in the Diagnosis and Management of Arterial Hypertension for Algerian Patients in Current Medical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Hypertension
Keywords: Hypertension
ABPM
Lead sponsor: Merinal Laboratoires
Sponsor class: INDUSTRY
Collaborators: name: Axelys Sante Dz
First posted: 2018-07-31
Enrollment: 1027
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In this observational study the target population will be constituted of patients who can benefit from the contribution of ABPM to confirm or refute (white coat effect) hypertension.

Brief summary: Blood pressure reduction and control are associated with reduced risk of stroke and cardiovascular disease. There is evidence that ambulatory blood pressure monitoring (ABPM) results more accurately reflect the risk of cardiovascular events than do office measurements of blood pressure. New international guidelines recognize the importance of ABPM which has an important and growing role in the diagnosis and in guiding antihypertensive therapy. In 2011 in the United Kingdom, the National Institute for Health and Care Excellence (NICE) recommended that ABPM be performed on all patients with suspected hypertension to confirm the diagnosis and reduce unnecessary treatment in people who do not have true hypertension. The aim of this observational study is to describe the utility of ABPM generally and specifically in the management of hypertension by Cardiologists in the Algerian context.

Detailed description: The primary Objective of this study is to assess the benefit of the ABPM in the diagnosis and management of arterial hypertension in by Cardiologists.

The Secondary Objectives are:

* To identify the conditions of usage of ABPM for the diagnosis of arterial hypertension,
* To evaluate the blood pressure during the ABPM assessment and at 6 weeks of follow up
* To describe the study population (socio-demography),
* To describe the therapeutic stratégies and the compliance to treatment.

Eligibility criteria: Inclusion Criteria:

* Patients who are either hypertensive (defined as those with a clinic SBP ≥ 140 mmHg or DBP ≥ 90 mmHg \[7\]) or referred for the assessment of hypertension
* Informed consent obtained before any study-related activity

Exclusion Criteria:

* ABPM contraindication
* Patient with psychiatric disorder
* Patient not able to comply with study-related procedures based on clinical judgement of the investigator

Primary outcomes:
measure: Diagnosis of hypertension
timeFrame: At 24 hours after the inclusion in the study (Visit 2)
Secondary outcomes:
measure: Patient Demography
timeFrame: At the Inclusion in the study
measure: Therapeutic Decison
timeFrame: At 24 hours after the inclusion in the study (Visit 2)
measure: Self-measurement of Arterial blood Pressure
timeFrame: At 6 weeks after the inclusion in the study (Visit 3)
measure: Evaluation of Compliance to treatment
timeFrame: At 6 weeks after the inclusion in the study (Visit 3)
Other outcomes:
Locations:
city: Alger
country: Algeria
facility: Service de cardiologie EHS Maouche ( ex CNMS de Benaknoun)
Study officials:
References:
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citation: Bachir Cherif A, Temmar M, Labat C, Atif L, Chibane A, Benkhedda S, Taleb A, Benfenatki N, Benetos A, Bouafia MT. [Cardiovascular morbimortality after a follow-up of six years in black hypertensive in South Algeria]. Ann Cardiol Angeiol (Paris). 2014 Jun;63(3):168-75. doi: 10.1016/j.ancard.2014.04.019. Epub 2014 May 15. French.
citation: Hammoudi-Bendib N, Manamani L, Ouabdesselam S, Ouamer DS, Ghemri S, Courouve L, Cherif A, Mahi L, Benkhedda S. Ambulatory Blood Pressure Monitoring in the Diagnosis and Management of Arterial Hypertension in Current Medical Practice in Algeria. Curr Hypertens Rev. 2021;17(1):75-82. doi: 10.2174/1573402116666200324144223.