<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03774147</url>
  </required_header>
  <id_info>
    <org_study_id>2014-A01536-41</org_study_id>
    <nct_id>NCT03774147</nct_id>
  </id_info>
  <brief_title>24-hour Ambulatory Blood Pressure Monitoring in Patients With Blood Pressure Above Thresholds in General Practice</brief_title>
  <acronym>MAPAGE</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>University of Burgundy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Association pour le Développement de la Recherche en Médecine Générale (ADRMG)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Département de Médecine Générale de Dijon (DMG)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Burgundy</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      High blood pressure (HBP) is a major modifiable cardiovascular risk factor which prevalence&#xD;
      is gradually increasing. Reducing blood pressure (BP) significantly decreases cardiovascular&#xD;
      morbi-mortality. Nevertheless, BP control remains insufficient: only 51% of French patients&#xD;
      using antihypertensive drugs achieve the BP control targets.&#xD;
&#xD;
      HBP is mostly diagnosed and managed in primary care. Nevertheless, office BP measurements are&#xD;
      unreliable for BP control and poorer predict target organ damage. Ambulatory BP measurements&#xD;
      are recommended for HBP diagnosis and follow-up. 24-hour ambulatory blood pressure monitoring&#xD;
      (ABPM) is the most cost-effective strategy. Its superiority has been demonstrated for HBP&#xD;
      diagnosis and cardiovascular prognosis.&#xD;
&#xD;
      In France, ABPM is poorly available and little studied in primary care. Therefore, the&#xD;
      investigators conducted a regional prospective study to analyze the feasibility and benefits&#xD;
      of ABPM among primary care hypertensive patients in daily practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 2015</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of white-coat hypertension</measure>
    <time_frame>at the time of ABPM, up to 30 days after the inclusion consultation</time_frame>
    <description>Proportion of patients with normotension in ABPM (daytime systolic/diastolic BP&lt; 135/85 mmHg AND/OR nighttime BP&lt; 120/70 mmHg AND/OR 24-hour BP&lt; 130/80 mmHg) among the patients with primary care office measured BP≥ 140/90 mmHg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of nocturnal hypertension</measure>
    <time_frame>at the time of ABPM, up to 30 days after the inclusion consultation</time_frame>
    <description>Proportion of patients with nocturnal high blood pressure in ABPM (nighttime systolic/diastolic BP&gt; 120/70 mmHg) among the patients with primary care office measured BP≥ 140/90 mmHg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of diurnal hypertension</measure>
    <time_frame>at the time of ABPM, up to 30 days after the inclusion consultation</time_frame>
    <description>Proportion of patients with diurnal high blood pressure in ABPM (daytime systolic/diastolic BP&gt; 135/85 mmHg) among the patients with primary care office measured BP≥ 140/90 mmHg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of 24-hour hypertension</measure>
    <time_frame>at the time of ABPM, up to 30 days after the inclusion consultation</time_frame>
    <description>Proportion of patients with 24-hour high blood pressure in ABPM (24-hour systolic/diastolic BP&gt; 130/80 mmHg) among the patients with primary care office measured BP≥ 140/90 mmHg</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dipping</measure>
    <time_frame>at the time of ABPM, up to 30 days after the inclusion consultation</time_frame>
    <description>Proportion of nighttime mean BP fall, compared to daytime mean BP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ABPM acceptability</measure>
    <time_frame>at the time of ABPM, up to 30 days after the inclusion consultation</time_frame>
    <description>Number of patients who have undergone/completed the ABPM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ABPM validity</measure>
    <time_frame>at the time of ABPM, up to 30 days after the inclusion consultation</time_frame>
    <description>Number of patients who have had an invalid ABPM according to the criteria of the European society of cardiology</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ABPM side effects</measure>
    <time_frame>at the time of ABPM, up to 30 days after the inclusion consultation</time_frame>
    <description>Number of major side effects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Deprivation among hypertensive patients</measure>
    <time_frame>at the time of ABPM, up to 30 days after the inclusion consultation</time_frame>
    <description>Deprivation status of hypertensive primary care patients, according to the French Assessment of deprivation in Health Examination Centers' (EPICES) score (deprivation if EPICES score&gt; 30)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1067</enrollment>
  <condition>Hypertension</condition>
  <condition>Blood Pressure Monitoring, Ambulatory</condition>
  <condition>Primary Health Care</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>24-hour Ambulatory Blood Pressure Monitoring (ABPM)</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Twenty-three general practitioners located in the four departments of the Burgundy region&#xD;
        and practising in seven different health structures were recruited on a voluntary basis.&#xD;
&#xD;
        Primary care patients with an office high blood pressure were included, whatever their&#xD;
        reason for consultation, medical past history or ongoing treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  patients aged over 18 years&#xD;
&#xD;
          -  with an office inclusion consultation systolic/diastolic BP≥ 140/90 mmHg&#xD;
&#xD;
          -  able to understand French language and to consent to participate in the study&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  patients aged &lt; 18 years&#xD;
&#xD;
          -  with conditions preventing technically adequate ABPM (chronic atrial fibrillation)&#xD;
&#xD;
          -  with contraindications to ABPM (musculotendinous disease of the upper limb, past&#xD;
             history of phlebitis of the upper limb or phlebitis in progress, past history of&#xD;
             olecranon bursitis or bursitis in progress)&#xD;
&#xD;
          -  with previous ABPM in the 12 months prior to the inclusion consultation&#xD;
&#xD;
          -  pregnant or lactating women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Groupements des Professionnels de Santé du Pays Beaunois</name>
      <address>
        <city>Beaune</city>
        <zip>21200</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Maison Universitaire de Santé et de Soins Primaires</name>
      <address>
        <city>Chenove</city>
        <zip>21300</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claire ZABAWA</last_name>
      <phone>+33 6 99 83 53 26</phone>
      <email>claire.zabawa@u-bourgogne.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cabinet de médecine générale</name>
      <address>
        <city>Garchizy</city>
        <zip>58600</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Maison de santé de Terre Pleine</name>
      <address>
        <city>Guillon</city>
        <zip>89420</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Maison de Santé Pluridisciplinaire</name>
      <address>
        <city>Montret</city>
        <zip>71440</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claire ZABAWA</last_name>
      <phone>+33 6 99 83 53 26</phone>
      <email>claire.zabawa@u-bourgogne.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Groupement des Professionnels de Santé de l'Auxois Sud</name>
      <address>
        <city>Pouilly-en-Auxois</city>
        <zip>21320</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claire ZABAWA</last_name>
      <phone>+33 6 99 83 53 26</phone>
      <email>claire.zabawa@u-bourgogne.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Maison de santé de l'Esplanade</name>
      <address>
        <city>Tournus</city>
        <zip>71700</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claire ZABAWA</last_name>
      <phone>+33 6 99 83 53 26</phone>
      <email>claire.zabawa@u-bourgogne.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>December 10, 2018</last_update_submitted>
  <last_update_submitted_qc>December 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Burgundy</investigator_affiliation>
    <investigator_full_name>Dr Claire ZABAWA</investigator_full_name>
    <investigator_title>University senior registrar</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03774147
org study id: 2014-A01536-41
nct id: NCT03774147
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Case-Only
time perspective: Prospective
measure: Prevalence of white-coat hypertension
time frame: at the time of ABPM, up to 30 days after the inclusion consultation
description: 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
measure: Prevalence of nocturnal hypertension
time frame: at the time of ABPM, up to 30 days after the inclusion consultation
description: 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
measure: Prevalence of diurnal hypertension
time frame: at the time of ABPM, up to 30 days after the inclusion consultation
description: 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
measure: Prevalence of 24-hour hypertension
time frame: at the time of ABPM, up to 30 days after the inclusion consultation
description: 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
measure: Dipping
time frame: at the time of ABPM, up to 30 days after the inclusion consultation
description: Proportion of nighttime mean BP fall, compared to daytime mean BP
measure: ABPM acceptability
time frame: at the time of ABPM, up to 30 days after the inclusion consultation
description: Number of patients who have undergone/completed the ABPM
measure: ABPM validity
time frame: at the time of ABPM, up to 30 days after the inclusion consultation
description: Number of patients who have had an invalid ABPM according to the criteria of the European society of cardiology
measure: ABPM side effects
time frame: at the time of ABPM, up to 30 days after the inclusion consultation
description: Number of major side effects
measure: Deprivation among hypertensive patients
time frame: at the time of ABPM, up to 30 days after the inclusion consultation
description: 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)
intervention type: Device
intervention name: 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Suspended
facility: 
status: Recruiting
contact: 
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Principal Investigator
investigator affiliation: University of Burgundy
investigator full name: Dr Claire ZABAWA
investigator title: University senior registrar
mesh term: Hypertension
sharing ipd: No