Diagnosis and Management of Arterial Hypertension for Algerian Patients in Current Medical Practice (MAPADZ)

ABPM (Automatic Measurement of Blood Pressure) Evaluation in the Diagnosis and Management of Arterial Hypertension for Algerian Patients in Current Medical Practice

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.

Study Overview

• Status: Completed
• Conditions: Arterial Hypertension

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.

• Study Type: Observational
• Enrollment (Actual): 1027

Contacts and Locations

Study Locations

• Algeria
  • Alger, Algeria
    • Service de cardiologie EHS Maouche ( ex CNMS de Benaknoun)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of hypertension	Valid 24h-ABPM: blood pressure ≥ 140/90 mmHg	At 24 hours after the inclusion in the study (Visit 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Demography	Age, Sexe	At the Inclusion in the study
Therapeutic Decison	Initiation of antihypertensive therapy in naive patients if the dianosis of hypertension is confirmed.; Maintain, switch or adaptation of treatment in treated patients.	At 24 hours after the inclusion in the study (Visit 2)
Self-measurement of Arterial blood Pressure	Measurement of arterial pressure performed by the patient and reported on a follow up diary. Both systolic and diastolic pressures will be collected.	At 6 weeks after the inclusion in the study (Visit 3)
Evaluation of Compliance to treatment	Evaluation test based on the method developed by Xavier Girerd, consisting in 6 questions on the compliance. The rating is divised in three categories: Good compliant, moderate compliant or non compliant. according to Girerd et al. Evaluation de l'observance par l'interrogatoire au cours du suivi des hypertendus dans des consultations spécialisées - Arch Mal Cœur Vaiss. 2001 Aug. 94-(8):839-42.	At 6 weeks after the inclusion in the study (Visit 3)

Collaborators and Investigators

• Sponsor: Merinal Laboratoires
• Collaborators: Axelys Sante Dz

Publications and helpful links

General Publications

• Nansseu JR, Noubiap JJ, Mengnjo MK, Aminde LN, Essouma M, Jingi AM, Bigna JJ. The highly neglected burden of resistant hypertension in Africa: a systematic review and meta-analysis. BMJ Open. 2016 Sep 20;6(9):e011452. doi: 10.1136/bmjopen-2016-011452.
• Nibouche WN, Biad A. [Arterial hypertension at the time of diagnosis of type 2 diabetes in adults]. Ann Cardiol Angeiol (Paris). 2016 Jun;65(3):152-8. doi: 10.1016/j.ancard.2016.04.017. Epub 2016 May 24. French.
• Amrani A, Baba Hamed MB, Mesli Talebbendiab F. Association study between some renin-angiotensin system gene variants and essential hypertension in a sample of Algerian population: case control study. Ann Biol Clin (Paris). 2015 Sep-Oct;73(5):557-63. doi: 10.1684/abc.2015.1069.
• Ghembaza MA, Senoussaoui Y, Tani MK, Meguenni K. Impact of patient knowledge of hypertension complications on adherence to antihypertensive therapy. Curr Hypertens Rev. 2014;10(1):41-8. doi: 10.2174/157340211001141111160653.
• Lardjam-Hetraf SA, Mediene-Benchekor S, Ouhaibi-Djellouli H, Meroufel DN, Boulenouar H, Hermant X, Hamani-Medjaoui I, Saidi-Mehtar N, Amouyel P, Houti L, Goumidi L, Meirhaeghe A. Effects of established blood pressure loci on blood pressure values and hypertension risk in an Algerian population sample. J Hum Hypertens. 2015 May;29(5):296-302. doi: 10.1038/jhh.2014.81. Epub 2014 Sep 18.
• 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.
• 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.

Helpful Links

• Feasibility survey on the use of ABPM in the management of hypertension

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2017
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: May 9, 2018
• First Submitted That Met QC Criteria: July 22, 2018
• First Posted (Actual): July 31, 2018

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: ABPM; Hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: ASDZ_Obs_01_2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No