<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/NCT03012295</url>
  </required_header>
  <id_info>
    <org_study_id>HYP-1000</org_study_id>
    <nct_id>NCT03012295</nct_id>
  </id_info>
  <brief_title>Genetic Testing of Monogenic Hypertension in Chinese Population</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese Academy of Medical Sciences, Fuwai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese Academy of Medical Sciences, Fuwai Hospital</source>
  <brief_summary>
    <textblock>
      Monogenic hypertension, which follows the rules of Mendel's genetic law, is one of the most&#xD;
      important causes of hypertension. Generally, patients occur hypertension in early age, have&#xD;
      family history, and often manifest severe hypertension or refractory hypertension. At&#xD;
      present, only a few hypertension centers of hospitals in China will help clinically difficult&#xD;
      diagnosis hypertensive patients to test some selective genes, while most of other hospitals&#xD;
      still perform diagnosis based on biochemical examination and clinical symptoms. Therefore, in&#xD;
      order to provide better guidance for the diagnosis and treatment for hypertensive patients,&#xD;
      this project aims to develop a single gene detection panel for genetic hypertension, so as to&#xD;
      provide new diagnostic technology for early intervention, prevention and treatment of&#xD;
      hypertension in clinics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2016</start_date>
  <primary_completion_date type="Anticipated">March 2017</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>number of genetic variants in Monogenic Hypertension patients as assessed by specific gene panel</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Monogenic Hypertension</condition>
  <eligibility>
    <study_pop>
      <textblock>
        High blood pressure outpatients and inpatients from national multi-hypertension center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hypertension patients meet one of the following criteria&#xD;
&#xD;
               1. Beginning age of hypertension: &lt;35 years (regardless of family history of&#xD;
                  hypertension);&#xD;
&#xD;
               2. refractory hypertension (blood pressure is difficult to control): triple&#xD;
                  antihypertensive drugs treatment for 1 months, 3 times of non-continuous high&#xD;
                  blood pressure in consulting room (SBP ≥140mmHg and/or DBP≥90mmHg);&#xD;
&#xD;
          -  patients suspected of secondary hypertension, meeting one of the following criteria&#xD;
&#xD;
               1. pheochromocytoma or Cushing syndrome;&#xD;
&#xD;
               2. hypertension with hypokalemia;&#xD;
&#xD;
               3. hypertension with hyperkalemia;&#xD;
&#xD;
               4. hypertension with special body shape, such as central obesity, moon face, acne&#xD;
                  etc..&#xD;
&#xD;
               5. adrenal tumor;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  renal parenchymal / renovascular hypertension&#xD;
&#xD;
          -  patients exceed age of 50, and with coronary heart disease and arteriosclerosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jun Cai, MD,Ph.D.</last_name>
    <phone>+86-010-88322161</phone>
    <email>caijun@fuwaihospital.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>CIFuwaiHospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ling Jin, Ph.D.</last_name>
      <email>jinling@fuwaihospital.org</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 4, 2017</last_update_submitted>
  <last_update_submitted_qc>January 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese Academy of Medical Sciences, Fuwai Hospital</investigator_affiliation>
    <investigator_full_name>Jun Cai</investigator_full_name>
    <investigator_title>director of hypertension center of Fuwai Hospital</investigator_title>
  </responsible_party>
  <keyword>Genetic Testing</keyword>
  <keyword>Chinese Population</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- 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/NCT03012295
org study id: HYP-1000
nct id: NCT03012295
lead sponsor: 
Monogenic hypertension, which follows the rules of Mendel's genetic law, is one of the most
      important causes of hypertension. Generally, patients occur hypertension in early age, have
      family history, and often manifest severe hypertension or refractory hypertension. At
      present, only a few hypertension centers of hospitals in China will help clinically difficult
      diagnosis hypertensive patients to test some selective genes, while most of other hospitals
      still perform diagnosis based on biochemical examination and clinical symptoms. Therefore, in
      order to provide better guidance for the diagnosis and treatment for hypertensive patients,
      this project aims to develop a single gene detection panel for genetic hypertension, so as to
      provide new diagnostic technology for early intervention, prevention and treatment of
      hypertension in clinics.
observational model: Cohort
time perspective: Prospective
measure: number of genetic variants in Monogenic Hypertension patients as assessed by specific gene panel
time frame: one year
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 50 Years
healthy volunteers: No
last name: Jun Cai, MD,Ph.D.
phone: +86-010-88322161
email: caijun@fuwaihospital.org
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
investigator full name: Jun Cai
investigator title: director of hypertension center of Fuwai Hospital
mesh term: Hypertension