NCT03607812

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,027

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

1.1 years

First QC Date

May 9, 2018

Last Update Submit

August 19, 2019

Conditions

Keywords

HypertensionABPM

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of hypertension

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

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

Secondary Outcomes (4)

  • Patient Demography

    At the Inclusion in the study

  • Therapeutic Decison

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

  • Self-measurement of Arterial blood Pressure

    At 6 weeks after the inclusion in the study (Visit 3)

  • Evaluation of Compliance to treatment

    At 6 weeks after the inclusion in the study (Visit 3)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • ABPM contraindication
  • Patient with psychiatric disorder
  • Patient not able to comply with study-related procedures based on clinical judgement of the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de cardiologie EHS Maouche ( ex CNMS de Benaknoun)

Algiers, Algeria

Location

Related Publications (7)

  • 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.

    PMID: 27650760BACKGROUND
  • 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.

    PMID: 27234335BACKGROUND
  • 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.

    PMID: 26489814BACKGROUND
  • 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. doi: 10.2174/157340211001141111160653.

    PMID: 25392143BACKGROUND
  • 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.

    PMID: 25231511BACKGROUND
  • 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.

    PMID: 24933716BACKGROUND
  • Hammoudi-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.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2018

First Posted

July 31, 2018

Study Start

June 28, 2017

Primary Completion

July 31, 2018

Study Completion

August 31, 2018

Last Updated

August 20, 2019

Record last verified: 2019-08

Locations