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

Hypertension Clinical Trial

— MAPAGE  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03774147
• Other study ID #: 2014-A01536-41
• Status: Recruiting
• Start date: July 2015
• Est. completion date: December 2019

Study information

• Verified date: December 2018
• Source: University of Burgundy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1067
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure Monitoring, Ambulatory
• Hypertension
• Primary Health Care

Intervention

Device:
• 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

Locations

Country	Name	City	State
France	Groupements des Professionnels de Santé du Pays Beaunois	Beaune
France	Maison Universitaire de Santé et de Soins Primaires	Chenove
France	Cabinet de médecine générale	Garchizy
France	Maison de santé de Terre Pleine	Guillon
France	Maison de Santé Pluridisciplinaire	Montret
France	Groupement des Professionnels de Santé de l'Auxois Sud	Pouilly-en-Auxois
France	Maison de santé de l'Esplanade	Tournus

Sponsors (3)

Lead Sponsor	Collaborator
University of Burgundy	Association pour le Développement de la Recherche en Médecine Générale (ADRMG), Département de Médecine Générale de Dijon (DMG)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	ABPM acceptability	Number of patients who have undergone/completed the ABPM	at the time of ABPM, up to 30 days after the inclusion consultation
Secondary	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
Secondary	ABPM side effects	Number of major side effects	at the time of ABPM, up to 30 days after the inclusion consultation
Secondary	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