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

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension; Primary Health Care; Blood Pressure Monitoring, Ambulatory
• Intervention / Treatment: Device: 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

• Study Type: Observational
• Enrollment (Anticipated): 1067

Contacts and Locations

Study Locations

• France
  • Beaune, France, 21200
    • Suspended
    • Groupements des Professionnels de Santé du Pays Beaunois
  • Chenove, France, 21300
    • Recruiting
    • Maison Universitaire de Santé et de Soins Primaires
    • Contact: Claire ZABAWA; Phone Number: +33 6 99 83 53 26; Email: claire.zabawa@u-bourgogne.fr
  • Garchizy, France, 58600
    • Suspended
    • Cabinet de médecine générale
  • Guillon, France, 89420
    • Suspended
    • Maison de santé de Terre Pleine
  • Montret, France, 71440
    • Recruiting
    • Maison de Santé Pluridisciplinaire
    • Contact: Claire ZABAWA; Phone Number: +33 6 99 83 53 26; Email: claire.zabawa@u-bourgogne.fr
  • Pouilly-en-Auxois, France, 21320
    • Recruiting
    • Groupement des Professionnels de Santé de l'Auxois Sud
    • Contact: Claire ZABAWA; Phone Number: +33 6 99 83 53 26; Email: claire.zabawa@u-bourgogne.fr
  • Tournus, France, 71700
    • Recruiting
    • Maison de santé de l'Esplanade
    • Contact: Claire ZABAWA; Phone Number: +33 6 99 83 53 26; Email: claire.zabawa@u-bourgogne.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of white-coat hypertension	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	at the time of ABPM, up to 30 days after the inclusion consultation
Prevalence of nocturnal hypertension	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	at the time of ABPM, up to 30 days after the inclusion consultation
Prevalence of diurnal hypertension	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	at the time of ABPM, up to 30 days after the inclusion consultation
Prevalence of 24-hour hypertension	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	at the time of ABPM, up to 30 days after the inclusion consultation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dipping	Proportion of nighttime mean BP fall, compared to daytime mean BP	at the time of ABPM, up to 30 days after the inclusion consultation
ABPM acceptability	Number of patients who have undergone/completed the ABPM	at the time of ABPM, up to 30 days after the inclusion consultation
ABPM validity	Number of patients who have had an invalid ABPM according to the criteria of the European society of cardiology	at the time of ABPM, up to 30 days after the inclusion consultation
ABPM side effects	Number of major side effects	at the time of ABPM, up to 30 days after the inclusion consultation
Deprivation among hypertensive patients	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)	at the time of ABPM, up to 30 days after the inclusion consultation

Collaborators and Investigators

• Sponsor: University of Burgundy
• Collaborators: Association pour le Développement de la Recherche en Médecine Générale (ADRMG); Département de Médecine Générale de Dijon (DMG)

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: December 4, 2018
• First Submitted That Met QC Criteria: December 10, 2018
• First Posted (Actual): December 12, 2018

Study Record Updates

• Last Update Posted (Actual): December 12, 2018
• Last Update Submitted That Met QC Criteria: December 10, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 2014-A01536-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No