Arterial HypertensionMAPADZNCT03607812
Diagnosis and Management of Arterial Hypertension for Algerian Patients in Current Medical Practice
An observational study of Arterial Hypertension, run by Merinal Laboratoires at 1 site in Algeria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Hypertension
- How many people
- 1,027 participants
- Where
- 1 siteAlgeria
- Study dates
- 28 Jun 2017to 31 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- ABPM contraindication
- Patient with psychiatric disorder
- Patient not able to comply with study-related procedures based on clinical judgement of the investigator
Trial locations and contacts
1 site in 1 country.
Algeria1 site
Service de cardiologie EHS Maouche ( ex CNMS de Benaknoun)
Algiers
About this study
Official title: 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.
Read the 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.
- Conditions
- Arterial Hypertension
- Keywords
- Hypertension, ABPM
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of hypertension
Valid 24h-ABPM: blood pressure ≥ 140/90 mmHg
Measured: At 24 hours after the inclusion in the study (Visit 2)
Secondary outcomes (4)
Patient Demography
Age, Sexe
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 6 weeks after the inclusion in the study (Visit 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start28 Jun 2017
- Primary completion31 Jul 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,027 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merinal Laboratoires
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Axelys Sante Dz
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607812
- Sponsor's protocol ID
- ASDZ_Obs_01_2017
- Acronym
- MAPADZ
- Status last verified
- Aug 2019
- First submitted
- 9 May 2018
- Last updated
- 20 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 27650760Nibouche 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.
PubMed 27234335Amrani 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.
PubMed 26489814Ghembaza 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.
PubMed 25392143Lardjam-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.
PubMed 25231511Bachir 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.
PubMed 24933716Hammoudi-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.
PubMed 32208121
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABPM (Automatic Measurement of Blood Pressure) Evaluation in the Diagnosis and Management of Arterial Hypertension for Algerian Patients in Current Medical Practice
- ClinicalTrials.gov ID
- NCT03607812
- Acronym / sponsor ID
- MAPADZ / ASDZ_Obs_01_2017
- Conditions
- Arterial Hypertension
- Keywords
- Hypertension, ABPM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,027 participants (actual)
- Lead sponsor
- Merinal LaboratoiresIndustry (pharma, biotech, devices)
- Collaborators
- Axelys Sante Dz
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- ABPM contraindication
- Patient with psychiatric disorder
- Patient not able to comply with study-related procedures based on clinical judgement of the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis of hypertension
Time frame: At 24 hours after the inclusion in the study (Visit 2)
Valid 24h-ABPM: blood pressure ≥ 140/90 mmHg
4 secondary outcomes
Patient Demography
Time frame: At the Inclusion in the study
Therapeutic Decison
Time frame: At 24 hours after the inclusion in the study (Visit 2)
Self-measurement of Arterial blood Pressure
Time frame: At 6 weeks after the inclusion in the study (Visit 3)
Evaluation of Compliance to treatment
Time frame: At 6 weeks after the inclusion in the study (Visit 3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Background: PubMed 27650760Nansseu 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.
- Background: PubMed 27234335Nibouche 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.
- Background: PubMed 26489814Amrani 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.
- Background: PubMed 25392143Ghembaza 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.
- Background: PubMed 25231511Lardjam-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.
- Background: PubMed 24933716Bachir 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.
- Derived from this study: PubMed 32208121Hammoudi-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Hypertension, run by Merinal Laboratoires at 1 site in Algeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Algeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of hypertension (time frame: At 24 hours after the inclusion in the study (Visit 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03607812, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.