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

Study Overview
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Brief Summary
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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.

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

Intervention / Treatment
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* Device: 24-hour Ambulatory Blood Pressure Monitoring (ABPM)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: 24-hour Ambulatory Blood Pressure Monitoring (ABPM)|nan|

What is the study measuring?
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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 |