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

• Conditions: Hypertension; Primary Health Care; Blood Pressure Monitoring, Ambulatory

• Registration Number: NCT03774147
• Lead Sponsor: University of Burgundy

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Status Verified: 2018-12
• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-10
• Last Update Submitted: 2018-12-10
• Study First Posted: 2018-12-12
• Last Update Posted: 2018-12-12
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1067

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of 24-hour hypertension	at the time of ABPM, up to 30 days after the inclusion consultation	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
Prevalence of nocturnal hypertension	at the time of ABPM, up to 30 days after the inclusion consultation	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
Prevalence of diurnal hypertension	at the time of ABPM, up to 30 days after the inclusion consultation	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
Prevalence of white-coat hypertension	at the time of ABPM, up to 30 days after the inclusion consultation	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

Secondary Outcome Measures

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

Trial Locations

Locations (7)

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, France