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

Completed

• Conditions: Arterial Hypertension

• Registration Number: NCT03607812
• Lead Sponsor: Merinal Laboratoires

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.

Study Timeline

• Study Start: 2017-06-28
• Study First Submitted: 2018-05-09
• Study First Submitted QC: 2018-07-22
• Primary Completion: 2018-07-31
• Study First Posted: 2018-07-31
• Study Completion: 2018-08-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1027

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Therapeutic Decison	At 24 hours after the inclusion in the study (Visit 2)	* Initiation of antihypertensive therapy in naive patients if the dianosis of hypertension is confirmed.; * Maintain, switch or adaptation of treatment in treated patients.
Self-measurement of Arterial blood Pressure	At 6 weeks after the inclusion in the study (Visit 3)	Measurement of arterial pressure performed by the patient and reported on a follow up diary. Both systolic and diastolic pressures will be collected.
Evaluation of Compliance to treatment	At 6 weeks after the inclusion in the study (Visit 3)	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.
Patient Demography	At the Inclusion in the study	Age, Sexe

Trial Locations

Locations (1)

Service de cardiologie EHS Maouche ( ex CNMS de Benaknoun); 🇩🇿 Alger, Algeria