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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03774147
Acronym
MAPAGE
Enrollment
1067
Registered
2018-12-12
Start date
2015-07-31
Completion date
2019-12-31
Last updated
2018-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Blood Pressure Monitoring, Ambulatory, Primary Health Care

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.

Interventions

Sponsors

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

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of white-coat hypertensionat the time of ABPM, up to 30 days after the inclusion consultationProportion 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
Prevalence of nocturnal hypertensionat the time of ABPM, up to 30 days after the inclusion consultationProportion 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
Prevalence of diurnal hypertensionat the time of ABPM, up to 30 days after the inclusion consultationProportion 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
Prevalence of 24-hour hypertensionat the time of ABPM, up to 30 days after the inclusion consultationProportion 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

MeasureTime frameDescription
Dippingat the time of ABPM, up to 30 days after the inclusion consultationProportion of nighttime mean BP fall, compared to daytime mean BP
Deprivation among hypertensive patientsat the time of ABPM, up to 30 days after the inclusion consultationDeprivation status of hypertensive primary care patients, according to the French Assessment of deprivation in Health Examination Centers' (EPICES) score (deprivation if EPICES score\> 30)
ABPM acceptabilityat the time of ABPM, up to 30 days after the inclusion consultationNumber of patients who have undergone/completed the ABPM
ABPM validityat the time of ABPM, up to 30 days after the inclusion consultationNumber of patients who have had an invalid ABPM according to the criteria of the European society of cardiology
ABPM side effectsat the time of ABPM, up to 30 days after the inclusion consultationNumber of major side effects

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026