HypertensionMAPAGENCT03774147
24-hour Ambulatory Blood Pressure Monitoring in Patients With Blood Pressure Above Thresholds in General Practice
An observational study of Hypertension and Blood Pressure Monitoring, Ambulatory, run by University of Burgundy at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Blood Pressure Monitoring, Ambulatory, Primary Health Care
- What is being tested?
- 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
- Type of treatment
- Medical device
- How many people
- 1,067 participants
- Where
- 7 sitesFrance
- Study dates
- Jul 2015to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites, 4 recruiting
- Suspended
Groupements des Professionnels de Santé du Pays Beaunois
Beaune, 21200
- Recruiting
Maison Universitaire de Santé et de Soins Primaires
Chenôve, 21300
Claire ZABAWA, +33 6 99 83 53 26, claire.zabawa@u-bourgogne.fr
- Suspended
Cabinet de médecine générale
Garchizy, 58600
- Suspended
Maison de santé de Terre Pleine
Guillon, 89420
- Recruiting
Maison de Santé Pluridisciplinaire
Montret, 71440
Claire ZABAWA, +33 6 99 83 53 26, claire.zabawa@u-bourgogne.fr
- Recruiting
Groupement des Professionnels de Santé de l'Auxois Sud
Pouilly-en-Auxois, 21320
Claire ZABAWA, +33 6 99 83 53 26, claire.zabawa@u-bourgogne.fr
- Recruiting
Maison de santé de l'Esplanade
Tournus, 71700
Claire ZABAWA, +33 6 99 83 53 26, claire.zabawa@u-bourgogne.fr
About this study
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.
- Being tested
- 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24-hour Ambulatory Blood Pressure Monitoring (ABPM)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: at the time of ABPM, up to 30 days after the inclusion consultation
Secondary outcomes (5)
Dipping
Proportion of nighttime mean BP fall, compared to daytime mean BP
Measured: at the time of ABPM, up to 30 days after the inclusion consultation
ABPM acceptability
Number of patients who have undergone/completed the ABPM
Measured: 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
Measured: at the time of ABPM, up to 30 days after the inclusion consultation
ABPM side effects
Number of major side effects
Measured: 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)
Measured: at the time of ABPM, up to 30 days after the inclusion consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study startJul 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,067 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Burgundy
- Sponsor type
- University, hospital or other
- Collaborators
- Association pour le Développement de la Recherche en Médecine Générale (ADRMG), Département de Médecine Générale de Dijon (DMG)
- Responsible party
- Principal investigator, Dr Claire ZABAWA, University of Burgundy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774147
- Sponsor's protocol ID
- 2014-A01536-41
- Acronym
- MAPAGE
- Status last verified
- Dec 2018
- First submitted
- 4 Dec 2018
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 24-hour Ambulatory Blood Pressure Monitoring in Patients With Blood Pressure Above Thresholds in General Practice
- ClinicalTrials.gov ID
- NCT03774147
- Acronym / sponsor ID
- MAPAGE / 2014-A01536-41
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,067 participants (estimated)
- Lead sponsor
- University of BurgundyUniversity, hospital or other
- Collaborators
- Association pour le Développement de la Recherche en Médecine Générale (ADRMG), Département de Médecine Générale de Dijon (DMG)
- Study start
- Jul 2015 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 12 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24-hour Ambulatory Blood Pressure Monitoring (ABPM) | Device | – |
Primary outcome
Prevalence of white-coat hypertension
Time frame: 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
Prevalence of nocturnal hypertension
Time frame: 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
Time frame: 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 24-hour hypertension
Time frame: 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
5 secondary outcomes
Dipping
Time frame: at the time of ABPM, up to 30 days after the inclusion consultation
ABPM acceptability
Time frame: at the time of ABPM, up to 30 days after the inclusion consultation
ABPM validity
Time frame: at the time of ABPM, up to 30 days after the inclusion consultation
ABPM side effects
Time frame: at the time of ABPM, up to 30 days after the inclusion consultation
Deprivation among hypertensive patients
Time frame: at the time of ABPM, up to 30 days after the inclusion consultation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maison Universitaire de Santé et de Soins Primaires
Chenôve, France
Groupement des Professionnels de Santé de l'Auxois Sud
Pouilly-en-Auxois, France
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Blood Pressure Monitoring, Ambulatory, run by University of Burgundy at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of white-coat hypertension (time frame: at the time of ABPM, up to 30 days after the inclusion consultation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2018.