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

Sponsor
Merinal Laboratoires (Industry)
Overall Status
Completed
CT.gov ID
NCT03607812
Collaborator
Axelys Sante Dz (Industry)
1,027
1
14.1
72.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    1027 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    ABPM (Automatic Measurement of Blood Pressure) Evaluation in the Diagnosis and Management of Arterial Hypertension for Algerian Patients in Current Medical Practice
    Actual Study Start Date :
    Jun 28, 2017
    Actual Primary Completion Date :
    Jul 31, 2018
    Actual Study Completion Date :
    Aug 31, 2018

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Patient Demography [At the Inclusion in the study]

      Age, Sexe

    2. 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.

    3. 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.

    4. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de cardiologie EHS Maouche ( ex CNMS de Benaknoun) Alger Algeria

    Sponsors and Collaborators

    • Merinal Laboratoires
    • Axelys Sante Dz

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Merinal Laboratoires
    ClinicalTrials.gov Identifier:
    NCT03607812
    Other Study ID Numbers:
    • ASDZ_Obs_01_2017
    First Posted:
    Jul 31, 2018
    Last Update Posted:
    Aug 20, 2019
    Last Verified:
    Aug 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Merinal Laboratoires
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 20, 2019