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Completed

NCT Number: NCT03607812

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de cardiologie EHS Maouche ( ex CNMS de Benaknoun)

Algiers, Algeria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diagnosis of hypertension

    Time frame: At 24 hours after the inclusion in the study (Visit 2)

    Valid 24h-ABPM: blood pressure ≥ 140/90 mmHg

Secondary outcomes

  1. Patient Demography

    Time frame: At the Inclusion in the study

    Age, Sexe

  2. Therapeutic Decison

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merinal Laboratoires

Industry

Collaborators

  • Axelys Sante Dz

Registry information

Official study title

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

Acronym: MAPADZ

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 31, 2018
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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