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

NCT03774147 | Unknown DMC

• 1 other identifier: 2014-A01536-41
• Study Type: observational
• Target: 1,067
• Locations: 1 country
• Sites: 7

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.

Conditions

Hypertension; Blood Pressure Monitoring, Ambulatory; Primary Health Care

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Dipping

  at the time of ABPM, up to 30 days after the inclusion consultation

• ABPM acceptability

  at the time of ABPM, up to 30 days after the inclusion consultation

• ABPM validity

  at the time of ABPM, up to 30 days after the inclusion consultation

• ABPM side effects

  at the time of ABPM, up to 30 days after the inclusion consultation

• Deprivation among hypertensive patients

  at the time of ABPM, up to 30 days after the inclusion consultation

Interventions

24-hour Ambulatory Blood Pressure Monitoring (ABPM) DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• patients aged over 18 years
• able to understand French language and to consent to participate in the study

You may not qualify if:

• 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)
• pregnant or lactating women

Sponsors & Collaborators

• University of Burgundy: lead
• Association pour le Développement de la Recherche en Médecine Générale (ADRMG): collaborator
• Département de Médecine Générale de Dijon (DMG): collaborator

Study Sites (7)

Groupements des Professionnels de Santé du Pays Beaunois

Beaune, 21200, France

SUSPENDED

Maison Universitaire de Santé et de Soins Primaires

Chenôve, 21300, France

RECRUITING

Cabinet de médecine générale

Garchizy, 58600, France

SUSPENDED

Maison de santé de Terre Pleine

Guillon, 89420, France

SUSPENDED

Maison de Santé Pluridisciplinaire

Montret, 71440, France

RECRUITING

Groupement des Professionnels de Santé de l'Auxois Sud

Pouilly-en-Auxois, 21320, France

RECRUITING

Maison de santé de l'Esplanade

Tournus, 71700, France

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Blood Pressure Monitoring, Ambulatory

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Blood Pressure Determination; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University senior registrar

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 12, 2018
• Study Start: July 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 12, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)