Clinical trial NCT03774147: 24-hour Ambulatory Blood Pressure Monitoring in Patients With Blood Pressure Above Thresholds in General Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Blood Pressure Monitoring, Ambulatory
Primary Health Care
Lead sponsor: University of Burgundy
Sponsor class: OTHER
Collaborators: name: Association pour le Développement de la Recherche en Médecine Générale (ADRMG)
name: Département de Médecine Générale de Dijon (DMG)
First posted: 2018-12-12
Enrollment: 1067
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Prevalence of white-coat hypertension
timeFrame: at the time of ABPM, up to 30 days after the inclusion consultation
measure: Prevalence of nocturnal hypertension
timeFrame: at the time of ABPM, up to 30 days after the inclusion consultation
measure: Prevalence of diurnal hypertension
timeFrame: at the time of ABPM, up to 30 days after the inclusion consultation
measure: Prevalence of 24-hour hypertension
timeFrame: at the time of ABPM, up to 30 days after the inclusion consultation
Secondary outcomes:
measure: Dipping
timeFrame: at the time of ABPM, up to 30 days after the inclusion consultation
measure: ABPM acceptability
timeFrame: at the time of ABPM, up to 30 days after the inclusion consultation
measure: ABPM validity
timeFrame: at the time of ABPM, up to 30 days after the inclusion consultation
measure: ABPM side effects
timeFrame: at the time of ABPM, up to 30 days after the inclusion consultation
measure: Deprivation among hypertensive patients
timeFrame: at the time of ABPM, up to 30 days after the inclusion consultation
Other outcomes:
Locations:
city: Beaune
country: France
facility: Groupements des Professionnels de Santé du Pays Beaunois
city: Chenove
country: France
facility: Maison Universitaire de Santé et de Soins Primaires
city: Garchizy
country: France
facility: Cabinet de médecine générale
city: Guillon
country: France
facility: Maison de santé de Terre Pleine
city: Montret
country: France
facility: Maison de Santé Pluridisciplinaire
city: Pouilly-en-Auxois
country: France
facility: Groupement des Professionnels de Santé de l'Auxois Sud
city: Tournus
country: France
facility: Maison de santé de l'Esplanade
Study officials:
References: