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

Arterial Hypertension Clinical Trial

— MAPADZ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03607812
• Other study ID #: ASDZ_Obs_01_2017
• Status: Completed
• Start date: June 28, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: August 2019
• Source: Merinal Laboratoires
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1027
• Est. completion date: August 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Hypertension
• Hypertension

Locations

Country	Name	City	State
Algeria	Service de cardiologie EHS Maouche ( ex CNMS de Benaknoun)	Alger

Sponsors (2)

Lead Sponsor	Collaborator
Merinal Laboratoires	Axelys Sante Dz

Country where clinical trial is conducted

Algeria, 

References & Publications (6)

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. — View 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of hypertension	Valid 24h-ABPM: blood pressure = 140/90 mmHg	At 24 hours after the inclusion in the study (Visit 2)
Secondary	Patient Demography	Age, Sexe	At the Inclusion in the study
Secondary	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)
Secondary	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)
Secondary	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)

External Links

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