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24-hour Ambulatory Blood Pressure Monitoring in Patients With Blood Pressure Above Thresholds in General Practice (MAPAGE)

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ClinicalTrials.gov Identifier: NCT03774147
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Collaborators:
Association pour le Développement de la Recherche en Médecine Générale (ADRMG)
Département de Médecine Générale de Dijon (DMG)
Information provided by (Responsible Party):
Dr Claire ZABAWA, University of Burgundy

Brief Summary:

High blood pressure (HBP) is a major modifiable cardiovascular risk factor which prevalence is gradually increasing. Reducing blood pressure (BP) significantly decreases cardiovascular morbi-mortality. Nevertheless, BP control remains insufficient: only 51% of French patients using antihypertensive drugs achieve the BP control targets.

HBP is mostly diagnosed and managed in primary care. Nevertheless, office BP measurements are unreliable for BP control and poorer predict target organ damage. Ambulatory BP measurements are recommended for HBP diagnosis and follow-up. 24-hour ambulatory blood pressure monitoring (ABPM) is the most cost-effective strategy. Its superiority has been demonstrated for HBP diagnosis and cardiovascular prognosis.

In France, ABPM is poorly available and little studied in primary care. Therefore, the investigators conducted a regional prospective study to analyze the feasibility and benefits of ABPM among primary care hypertensive patients in daily practice.


Condition or disease Intervention/treatment
Hypertension Blood Pressure Monitoring, Ambulatory Primary Health Care Device: 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

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Study Type : Observational
Estimated Enrollment : 1067 participants
Observational Model: Case-Only
Time Perspective: Prospective
Actual Study Start Date : July 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Prevalence of white-coat hypertension [ Time Frame: at the time of ABPM, up to 30 days after the inclusion consultation ]
    Proportion of patients with normotension in ABPM (daytime systolic/diastolic BP< 135/85 mmHg AND/OR nighttime BP< 120/70 mmHg AND/OR 24-hour BP< 130/80 mmHg) among the patients with primary care office measured BP≥ 140/90 mmHg

  2. Prevalence of nocturnal hypertension [ Time Frame: at the time of ABPM, up to 30 days after the inclusion consultation ]
    Proportion of patients with nocturnal high blood pressure in ABPM (nighttime systolic/diastolic BP> 120/70 mmHg) among the patients with primary care office measured BP≥ 140/90 mmHg

  3. Prevalence of diurnal hypertension [ Time Frame: at the time of ABPM, up to 30 days after the inclusion consultation ]
    Proportion of patients with diurnal high blood pressure in ABPM (daytime systolic/diastolic BP> 135/85 mmHg) among the patients with primary care office measured BP≥ 140/90 mmHg

  4. Prevalence of 24-hour hypertension [ Time Frame: at the time of ABPM, up to 30 days after the inclusion consultation ]
    Proportion of patients with 24-hour high blood pressure in ABPM (24-hour systolic/diastolic BP> 130/80 mmHg) among the patients with primary care office measured BP≥ 140/90 mmHg


Secondary Outcome Measures :
  1. Dipping [ Time Frame: at the time of ABPM, up to 30 days after the inclusion consultation ]
    Proportion of nighttime mean BP fall, compared to daytime mean BP

  2. ABPM acceptability [ Time Frame: at the time of ABPM, up to 30 days after the inclusion consultation ]
    Number of patients who have undergone/completed the ABPM

  3. ABPM validity [ Time Frame: at the time of ABPM, up to 30 days after the inclusion consultation ]
    Number of patients who have had an invalid ABPM according to the criteria of the European society of cardiology

  4. ABPM side effects [ Time Frame: at the time of ABPM, up to 30 days after the inclusion consultation ]
    Number of major side effects

  5. Deprivation among hypertensive patients [ Time Frame: at the time of ABPM, up to 30 days after the inclusion consultation ]
    Deprivation status of hypertensive primary care patients, according to the French Assessment of deprivation in Health Examination Centers' (EPICES) score (deprivation if EPICES score> 30)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Twenty-three general practitioners located in the four departments of the Burgundy region and practising in seven different health structures were recruited on a voluntary basis.

Primary care patients with an office high blood pressure were included, whatever their reason for consultation, medical past history or ongoing treatment

Criteria

Inclusion criteria:

  • patients aged over 18 years
  • with an office inclusion consultation systolic/diastolic BP≥ 140/90 mmHg
  • able to understand French language and to consent to participate in the study

Exclusion criteria:

  • patients aged < 18 years
  • with conditions preventing technically adequate ABPM (chronic atrial fibrillation)
  • with contraindications to ABPM (musculotendinous disease of the upper limb, past history of phlebitis of the upper limb or phlebitis in progress, past history of olecranon bursitis or bursitis in progress)
  • with previous ABPM in the 12 months prior to the inclusion consultation
  • pregnant or lactating women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774147


Locations
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France
Groupements des Professionnels de Santé du Pays Beaunois Suspended
Beaune, France, 21200
Maison Universitaire de Santé et de Soins Primaires Recruiting
Chenove, France, 21300
Contact: Claire ZABAWA    +33 6 99 83 53 26    claire.zabawa@u-bourgogne.fr   
Cabinet de médecine générale Suspended
Garchizy, France, 58600
Maison de santé de Terre Pleine Suspended
Guillon, France, 89420
Maison de Santé Pluridisciplinaire Recruiting
Montret, France, 71440
Contact: Claire ZABAWA    +33 6 99 83 53 26    claire.zabawa@u-bourgogne.fr   
Groupement des Professionnels de Santé de l'Auxois Sud Recruiting
Pouilly-en-Auxois, France, 21320
Contact: Claire ZABAWA    +33 6 99 83 53 26    claire.zabawa@u-bourgogne.fr   
Maison de santé de l'Esplanade Recruiting
Tournus, France, 71700
Contact: Claire ZABAWA    +33 6 99 83 53 26    claire.zabawa@u-bourgogne.fr   
Sponsors and Collaborators
University of Burgundy
Association pour le Développement de la Recherche en Médecine Générale (ADRMG)
Département de Médecine Générale de Dijon (DMG)
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Responsible Party: Dr Claire ZABAWA, University senior registrar, University of Burgundy
ClinicalTrials.gov Identifier: NCT03774147    
Other Study ID Numbers: 2014-A01536-41
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases