xml: <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/NCT05994274</url>
    </required_header>
    <id_info>
      <org_study_id>WuhanUH-XJH</org_study_id>
      <nct_id>NCT05994274</nct_id>
    </id_info>
    <brief_title>A Clinical Study of Association Between Postoperative Dyslipidemia and Organ Rejection in Transplant Patients</brief_title>
    <official_title>A Prospective Clinical Study of Association Between Postoperative Dyslipidemia and Organ</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wuhan Union Hospital, China</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Wuhan Union Hospital, China</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Abnormal lipid metabolism is a common complication after organ transplantation, with&#xD;
        pathological changes in lipid parameters occurring in approximately 60-80% of cardiac&#xD;
        transplant recipients receiving triple immunotherapy with cyclosporine, imid azathioprine,&#xD;
        and methylprednisolone. With the significant increase in long-term survival and increasing&#xD;
        age of transplant patients, atherosclerotic cardiovascular diseases, such as those caused by&#xD;
        dyslipidemia, have become a major cause of transplant organ failure and recipient death.&#xD;
        However, the causes of dyslipidemia after organ transplantation, as well as the effects and&#xD;
        mechanisms of dyslipidemia on transplant rejection, are unknown.&#xD;
  &#xD;
        Previous studies have found that 1. increased lipid levels occur in recipients after heart&#xD;
        transplantation; 2. during rejection, hepatic PCSK9 expression is increased in recipients; 3.&#xD;
        a high-fat environment increases the immunoreactivity of human peripheral blood lymphocytes.&#xD;
        It is suggested that PCSK9-lipid disorder-immune cell interactions may be associated with the&#xD;
        development of transplant rejection.&#xD;
  &#xD;
        In this project, we propose to (1) establish a long-term follow-up system for postoperative&#xD;
        cardiac transplantation patients in our department to track the characteristics of lipid&#xD;
        changes in transplantation patients, to clarify the link between dyslipidemia and rejection,&#xD;
        and to provide a strong evidence-based medical basis for the management of lipids during the&#xD;
        perioperative period and in the postoperative period; (2) expand the dimensions of&#xD;
        lipid-related assays under the support of the above system, and to incorporate&#xD;
        transcriptomic, proteomic, and metabolomic research methods to elucidate transplantation&#xD;
        rejection in a multidimensional manner. (ii) Expanding the dimensions of lipid-related assays&#xD;
        to include transcriptomic, proteomic, and metabolomic studies to elucidate the relationship&#xD;
        between PCSK9 and dyslipidemia in transplant patients; (iii) Adopting single-cell sequencing&#xD;
        technology to deeply reveal the potential mechanism by which changes in lipids affect&#xD;
        T-cell-mediated rejection of cardiac transplants. The mechanism of T-cell-mediated cardiac&#xD;
        transplantation rejection is revealed by single-cell sequencing.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">December 2027</completion_date>
    <primary_completion_date type="Anticipated">December 2027</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>Blood lipid measurements</measure>
      <time_frame>4 years</time_frame>
      <description>TG, TC, HDL-C, LDL-C, ApoB</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Graft/Patient survival</measure>
      <time_frame>4 years</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Left ventricular ejection fraction (LVEF) at rest</measure>
      <time_frame>4 years</time_frame>
      <description>determined by contrast echocardiography</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Heart Transplant Failure and Rejection</condition>
    <arm_group>
      <arm_group_label>HTx</arm_group_label>
      <description>Patients after heart transplantation.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who have undergone heart transplant.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  After heart transplantation&#xD;
  &#xD;
            -  Age ≥ 18&#xD;
  &#xD;
            -  Disease duration: symptomatic heart failure ≥ 6 months prior to screening date&#xD;
  &#xD;
            -  The patient's informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refusal of the patient to provide consent&#xD;
  &#xD;
            -  Suspected poor capability to follow instructions and cooperate&#xD;
  &#xD;
            -  Another life-threatening disease with poor prognosis (survival less than 2 years)&#xD;
  &#xD;
            -  Participation in any other clinical study within less than 30 days prior to screening&#xD;
               date&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jiahong Xia</last_name>
      <phone>(+0086)13971038472</phone>
      <email>jiahong.xia@mail.hust.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Wuhan Union Hospital</name>
        <address>
          <city>Wuhan</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jiahong Xia</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>heart transplantation</keyword>
    <keyword>Macrophages</keyword>
    <keyword>Fatty acid</keyword>
    <keyword>PCSK9</keyword>
    <keyword>Lipid metabolism</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dyslipidemias</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05994274
  org study id: WuhanUH-XJH
  nct id: NCT05994274
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Abnormal lipid metabolism is a common complication after organ transplantation, with
        pathological changes in lipid parameters occurring in approximately 60-80% of cardiac
        transplant recipients receiving triple immunotherapy with cyclosporine, imid azathioprine,
        and methylprednisolone. With the significant increase in long-term survival and increasing
        age of transplant patients, atherosclerotic cardiovascular diseases, such as those caused by
        dyslipidemia, have become a major cause of transplant organ failure and recipient death.
        However, the causes of dyslipidemia after organ transplantation, as well as the effects and
        mechanisms of dyslipidemia on transplant rejection, are unknown.
  
        Previous studies have found that 1. increased lipid levels occur in recipients after heart
        transplantation; 2. during rejection, hepatic PCSK9 expression is increased in recipients; 3.
        a high-fat environment increases the immunoreactivity of human peripheral blood lymphocytes.
        It is suggested that PCSK9-lipid disorder-immune cell interactions may be associated with the
        development of transplant rejection.
  
        In this project, we propose to (1) establish a long-term follow-up system for postoperative
        cardiac transplantation patients in our department to track the characteristics of lipid
        changes in transplantation patients, to clarify the link between dyslipidemia and rejection,
        and to provide a strong evidence-based medical basis for the management of lipids during the
        perioperative period and in the postoperative period; (2) expand the dimensions of
        lipid-related assays under the support of the above system, and to incorporate
        transcriptomic, proteomic, and metabolomic research methods to elucidate transplantation
        rejection in a multidimensional manner. (ii) Expanding the dimensions of lipid-related assays
        to include transcriptomic, proteomic, and metabolomic studies to elucidate the relationship
        between PCSK9 and dyslipidemia in transplant patients; (iii) Adopting single-cell sequencing
        technology to deeply reveal the potential mechanism by which changes in lipids affect
        T-cell-mediated rejection of cardiac transplants. The mechanism of T-cell-mediated cardiac
        transplantation rejection is revealed by single-cell sequencing.
  observational model: Cohort
  time perspective: Prospective
  measure: Blood lipid measurements
  time frame: 4 years
  description: TG, TC, HDL-C, LDL-C, ApoB
  measure: Graft/Patient survival
  time frame: 4 years
  measure: Left ventricular ejection fraction (LVEF) at rest
  time frame: 4 years
  description: determined by contrast echocardiography
  arm group label: HTx
  description: Patients after heart transplantation.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jiahong Xia
  phone: (+0086)13971038472
  email: jiahong.xia@mail.hust.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Dyslipidemias
  sharing ipd: No