<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/NCT03755726</url>
  </required_header>
  <id_info>
    <org_study_id>CHPAU2018/01</org_study_id>
    <nct_id>NCT03755726</nct_id>
  </id_info>
  <brief_title>A New Breath for Malignant Hypertension: Implementation of the HAMA Cohort</brief_title>
  <acronym>HAMA</acronym>
  <official_title>A New Breath for Malignant Hypertension: Implementation of the HAMA Cohort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier de PAU</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier de PAU</source>
  <oversight_info>
    <has_dmc>No</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>
      This registry aims to provide the first prospective, multicentric database of patients with&#xD;
      malignant hypertension. It will allow to assess modern epidemiology of the disease, diversity&#xD;
      of current management and care pathway, to deepen our pathophysiological knowledges, to&#xD;
      modernize the definition of this form of hypertension and its diagnostic criteria. The&#xD;
      network that will emerge will finally lead to the opportunity of setting up therapeutic&#xD;
      trials and establishing recommendations based on solid scientific evidence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Malignant hypertension is the most severe form of high blood pressure, fatal if left&#xD;
      untreated. It has not disappeared, with an increasing incidence. Patients with the disease,&#xD;
      mainly young (35 to 55 years of age), have an unfavorable cardiovascular prognosis (14% of&#xD;
      cardiovascular and renal events at 4 years). Despite these facts, scientific research on the&#xD;
      subject remains limited. The definitions and diagnostic criteria have not changed since 1929,&#xD;
      and the therapeutic recommendations remain empirical.&#xD;
&#xD;
      This first prospective and multicentric registry will increase and modernize the knowledge of&#xD;
      the disease. From these data, diagnostic and therapeutic recommendations based on solid&#xD;
      scientific evidence could be developed.&#xD;
&#xD;
      The investigators want to first recruit 500 patients and define their prognosis at 5 years.&#xD;
      The impact of the patient's phenotype, type and number of target organs affected will be&#xD;
      studied.&#xD;
&#xD;
      A modern definition, adapted to these results, could be proposed. The epidemiology of the&#xD;
      disease, the care pathways, the target organ disorders and the management carried out in the&#xD;
      centers will be described in detail.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 20, 2019</start_date>
  <completion_date type="Anticipated">September 20, 2029</completion_date>
  <primary_completion_date type="Anticipated">September 20, 2029</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>prognosis</measure>
    <time_frame>5 years</time_frame>
    <description>5-year prognosis for patients with malignant hypertension</description>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Malignant Hypertension</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with malignant hypertension&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Malignant hypertension according to the classic definition (Severe hypertension, above&#xD;
             180/110 associated with severe hypertensive retinopathy)&#xD;
&#xD;
          -  Severe hypertension (above 180/110) associated with acute damage of 3 target organ due&#xD;
             to high blood pressure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years old&#xD;
&#xD;
          -  Patients who cannot freely give their consent, or patients who refuse to participate&#xD;
&#xD;
          -  Dialysis&#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>CH d'Annecy</name>
      <address>
        <city>Annecy</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sandra JOST TURILLOT</last_name>
      <phone>04 50 63 65 22</phone>
      <email>sjostturrillot@ch-annecygenevois.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH de la côte Basque</name>
      <address>
        <city>Bayonne</city>
        <zip>64109</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Adeline Marie LACRAZ</last_name>
      <phone>05 59 44 38 64</phone>
      <email>alacraz@ch-cotebasque.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Avicenne APHP</name>
      <address>
        <city>Bobigny</city>
        <zip>93009</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marilucy LOPEZ SUBLET</last_name>
      <phone>01 48 95 53 91</phone>
      <email>marilucy.lopez-sublet@aphp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU - Hôpital St André</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philippe GOSSE</last_name>
      <phone>05 56 79 58 89</phone>
      <email>philippe.gosse@chu-bordeaux.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH de Chalon sur Saone</name>
      <address>
        <city>Chalon-sur-Saône</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maxime FAYARD</last_name>
      <phone>03 85 91 00 22</phone>
      <email>Maxime.Fayard@ch-chalon71.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH Métropole</name>
      <address>
        <city>Chambéry</city>
        <zip>73011</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stéphane BALLY</last_name>
      <phone>04 79 96 50 84</phone>
      <email>stephane.bally@ch-metropole-savoie.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Clermont FERRAND</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carole Philipponne</last_name>
      <phone>04 73 75 14 25</phone>
      <email>cphilipponnet@chu-clermontferrand.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Henri Mondor</name>
      <address>
        <city>Créteil</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Khalil El KAROUI</last_name>
      <phone>01 49 81 44 15</phone>
      <email>khalil.el-karoui@inserm.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH de Dinard</name>
      <address>
        <city>Dinard</city>
        <zip>35800</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thierry DENOLLE</last_name>
      <phone>02 99 46 75 17</phone>
      <email>denolle.thierry@wanadoo.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Michallon</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivier ORMEZZANO</last_name>
      <phone>04 76 76 54 37</phone>
      <email>OOrmezzano@chu-grenoble.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>hôpital de Haguenau</name>
      <address>
        <city>Haguenau</city>
        <zip>67504</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yves DIMITROV</last_name>
      <phone>03 88 06 33 30</phone>
      <email>yves.dimitrov@ch-haguenau.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pôle Santé Sud</name>
      <address>
        <city>Le Mans</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christophe BACHELET</last_name>
      <phone>02 43 78 45 90</phone>
      <email>christophe.bachelet@me.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH de Libourne</name>
      <address>
        <city>Libourne</city>
        <zip>33505</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Adrien KELLER</last_name>
      <phone>05 57 55 34 62</phone>
      <email>adrien.keller@ch-libourne.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHRU de Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pascal DELSART</last_name>
      <phone>03 20 44 54 63</phone>
      <email>Pascal.DELSART@chru-lille.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinique Vert Coteau</name>
      <address>
        <city>Marseille</city>
        <zip>13012</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michèle ESCANDE</last_name>
      <phone>04 91 18 65 33</phone>
      <email>micheleescande@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital de la conception</name>
      <address>
        <city>Marseille</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas ROBERT</last_name>
      <phone>04 91 38 30 42</phone>
      <email>Thomas.ROBERT@ap-hm.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH Martigues</name>
      <address>
        <city>Martigues</city>
        <zip>13500</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christophe BOUAKA</last_name>
      <phone>04 42 43 22 22</phone>
      <email>Christophe.BOUAKA@ch-martigues.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Montellier</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pierre FESLER</last_name>
      <phone>04 67 33 84 43</phone>
      <email>p-fesler@chu-montpellier.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU - Hôpital Laennec</name>
      <address>
        <city>Nantes</city>
        <zip>44800</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guillaume LAMIRAULT</last_name>
      <phone>02 40 08 23 43</phone>
      <email>guillaume.lamirault@chu-nantes.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Joseph</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yara HANON - ANTAKLY</last_name>
      <phone>01 44 12 79 13</phone>
      <email>YAntakly@hpsj.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Européen Georges Pompidou</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aurélien LORTHIOIR</last_name>
      <phone>01 56 09 37 76</phone>
      <email>aurelien.lorthioir@aphp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>APHP Bichat</name>
      <address>
        <city>Paris</city>
        <zip>75877</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emmenuelle VIDAL PETIOT</last_name>
      <phone>01 40 25 84 69</phone>
      <email>emmanuelle.vidal-petiot@aphp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fondation Adolphe de Rothschild</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benjamin MAIER</last_name>
      <phone>01 48 03 65 65</phone>
      <email>benjamin.maier025@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Tenon</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laurent MESNARD</last_name>
      <phone>01 56 01 65 02</phone>
      <email>laurent.mesnard@aphp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH de PAU</name>
      <address>
        <city>PAU</city>
        <zip>64000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Romain Boustreau</last_name>
      <phone>05 59 92 48 83</phone>
      <email>romain.boulestreau@ch-pau.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benoit LEQUEUX</last_name>
      <phone>05 49 44 44 44</phone>
      <email>Benoit.LEQUEUX@chu-poitiers.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Pointe à Pitre</name>
      <address>
        <city>Pîtres</city>
        <zip>97159</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Valérie ALOPH GALANTINE</last_name>
      <phone>05 90 89 13 27</phone>
      <email>valerie.aloph@chu-guadeloupe.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Caroline DOURMAP</last_name>
      <phone>02 99 28 25 08</phone>
      <email>caroline.dourmap-collas@chu-rennes.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de ROUEN</name>
      <address>
        <city>Rouen</city>
        <zip>76000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dominique GUERROT</last_name>
      <phone>02 32 88 90 15</phone>
      <email>Dominique.Guerrot@chu-rouen.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinique sainte Clotilde</name>
      <address>
        <city>Saint denis</city>
        <zip>97400</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lucas MORLON</last_name>
      <phone>02 62 48 20 20</phone>
      <email>lucasmorlon@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH de St Nazaire</name>
      <address>
        <city>Saint-Nazaire</city>
        <zip>44606</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sylvie LE COZ</last_name>
      <phone>02 72 27 82 72</phone>
      <email>s.regnier-lecoz@ch-saintnazaire.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de St Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Miriana DINIC</last_name>
      <phone>04 77 82 83 80</phone>
      <email>miriana.dinic@chu-st-etienne.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dominique STEPHAN</last_name>
      <phone>03.69.55.05.83</phone>
      <email>Dominique.stephan@chru-strasbourg.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Toulouse Rangueil</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Béatrice DULY-BOUHANICK</last_name>
      <phone>05-61-32-21-59</phone>
      <email>duly-bouhanick.b@chu-toulouse.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Tours</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean Michel HALIMI</last_name>
      <phone>02 47 47 37 46</phone>
      <email>halimi@med.univ-tours.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH de Valenciennes</name>
      <address>
        <city>Valenciennes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claire CARTERY</last_name>
      <phone>03 27 14 30 89</phone>
      <email>claire.cartery@dbmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>August 30, 2022</last_update_submitted>
  <last_update_submitted_qc>August 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier de PAU</investigator_affiliation>
    <investigator_full_name>Romain Boulestreau</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Hypertension, Malignant</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/NCT03755726
org study id: CHPAU2018/01
nct id: NCT03755726
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This registry aims to provide the first prospective, multicentric database of patients with
      malignant hypertension. It will allow to assess modern epidemiology of the disease, diversity
      of current management and care pathway, to deepen our pathophysiological knowledges, to
      modernize the definition of this form of hypertension and its diagnostic criteria. The
      network that will emerge will finally lead to the opportunity of setting up therapeutic
      trials and establishing recommendations based on solid scientific evidence.
Malignant hypertension is the most severe form of high blood pressure, fatal if left
      untreated. It has not disappeared, with an increasing incidence. Patients with the disease,
      mainly young (35 to 55 years of age), have an unfavorable cardiovascular prognosis (14% of
      cardiovascular and renal events at 4 years). Despite these facts, scientific research on the
      subject remains limited. The definitions and diagnostic criteria have not changed since 1929,
      and the therapeutic recommendations remain empirical.

      This first prospective and multicentric registry will increase and modernize the knowledge of
      the disease. From these data, diagnostic and therapeutic recommendations based on solid
      scientific evidence could be developed.

      The investigators want to first recruit 500 patients and define their prognosis at 5 years.
      The impact of the patient's phenotype, type and number of target organs affected will be
      studied.

      A modern definition, adapted to these results, could be proposed. The epidemiology of the
      disease, the care pathways, the target organ disorders and the management carried out in the
      centers will be described in detail.
observational model: Cohort
time perspective: Prospective
measure: prognosis
time frame: 5 years
description: 5-year prognosis for patients with malignant hypertension
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: France
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier de PAU
investigator full name: Romain Boulestreau
investigator title: Principal Investigator
mesh term: Hypertension
mesh term: Hypertension, Malignant
sharing ipd: No