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/NCT06026215</url>
    </required_header>
    <id_info>
      <org_study_id>2015CD001</org_study_id>
      <secondary_id>139009</secondary_id>
      <nct_id>NCT06026215</nct_id>
    </id_info>
    <brief_title>Assessing the Effects of Mechanical Unloading on Repair Version-1</brief_title>
    <official_title>Assessing the Effects of Mechanical Unloading on Tissue and Immunologic Characteristics Indictive of Cardiac Repair</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Manchester University NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Manchester University NHS Foundation Trust</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>
        The mechanism by which heart failure initiates and progresses and the mechanisms of heart&#xD;
        repair remain unclear.&#xD;
  &#xD;
        The left ventricular assist device (LVAD) is a therapy to stabilise patients while they await&#xD;
        their transplant. The LVAD helps pump blood around the body, giving the heart an opportunity&#xD;
        to recover. During surgery, the apical core tissue is routinely removed to allow the&#xD;
        implantation of the device (this tissue is normally discarded). Some patients demonstrate&#xD;
        cardiac recovery, allowing the device to be removed without later needing a transplant. As&#xD;
        part of the LVAD removal procedure, the section around the device might need to be removed&#xD;
        (this tissue is normally discarded). To further understand the cellular and molecular&#xD;
        mechanisms by which the heart is repaired, the investigators wish to utilise this surplus&#xD;
        tissue for research purposes. The collection of this tissue is part of routine treatment and&#xD;
        does not represent additional risk for the patient for research purposes. Some patients might&#xD;
        still require a transplant following VAD treatment. The native heart is removed from these&#xD;
        patients (routinely discarded) and replaced by a donor heart. The investigators wish to&#xD;
        utilise this discarded tissue for research purposes, so that the investigators can identify&#xD;
        the cellular and molecular factors involved in cardiac repair and which distinguish&#xD;
        responsive and non-responsive patients. Heart transplant recipients who require&#xD;
        extracorporeal membrane oxygenation will have an additional heart biopsy sample taken for&#xD;
        research purposes when performed as part of routine clinical practice. There is no additional&#xD;
        risk to the patient for research purposes. Heart failure patients scheduled for&#xD;
        transplantation (who have not received a VAD) will be recruited prior to transplantation and&#xD;
        their native heart retained for research purposes. An additional peripheral blood sample will&#xD;
        be collected from all patients for research purposes when performed for routine clinical&#xD;
        practice.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 15, 2015</start_date>
    <completion_date type="Actual">May 31, 2019</completion_date>
    <primary_completion_date type="Actual">May 31, 2019</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>Changes in protein expression within the tissue during clinical repair.</measure>
      <time_frame>through study completion - 4 years</time_frame>
      <description>Relate small changes in protein expression within the heart tissue to clinical parameters indicative of function. Additionally, the investigators aim to extend our understanding of the mechanisms underpinning heart failure by identifying the factors responsible for either preventing repair or promoting expedited disease progression.</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">23</enrollment>
    <condition>Heart Failure</condition>
    <condition>Transplant; Failure, Heart</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
      <description>Heart failure patients requiring ventricular assist device implantation will be included into group 1.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2</arm_group_label>
      <description>Heart transplant recipients requiring early extracorporeal membrane oxygenation will be recruited into group 2.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 3</arm_group_label>
      <description>Heart transplant recipients who have not previously received a VAD will be recruited into group 3.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Chronic heart failure and require mechanical unloading using a left ventricular assist&#xD;
          device.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients must be able to provide informed consent; informed consent may be provided&#xD;
               retrospectively if this cannot be provided pre-surgery.&#xD;
  &#xD;
            -  Patients must be aged between 18--70 years of age.&#xD;
  &#xD;
            -  Patients who have been clinically diagnosed with chronic heart failure and require&#xD;
               mechanical unloading using a left ventricular assist device.&#xD;
  &#xD;
            -  Patients who have received a heart transplant but require extracorporeal membrane&#xD;
               oxygenation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients under 18 or over 70 years of age.&#xD;
  &#xD;
            -  Patients unable to provide informed consent.&#xD;
  &#xD;
            -  Patients who are prisoners.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</mesh_term>
    </condition_browse>
    <!-- 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/NCT06026215
  org study id: 2015CD001
  secondary id: 139009
  nct id: NCT06026215
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The mechanism by which heart failure initiates and progresses and the mechanisms of heart
        repair remain unclear.
  
        The left ventricular assist device (LVAD) is a therapy to stabilise patients while they await
        their transplant. The LVAD helps pump blood around the body, giving the heart an opportunity
        to recover. During surgery, the apical core tissue is routinely removed to allow the
        implantation of the device (this tissue is normally discarded). Some patients demonstrate
        cardiac recovery, allowing the device to be removed without later needing a transplant. As
        part of the LVAD removal procedure, the section around the device might need to be removed
        (this tissue is normally discarded). To further understand the cellular and molecular
        mechanisms by which the heart is repaired, the investigators wish to utilise this surplus
        tissue for research purposes. The collection of this tissue is part of routine treatment and
        does not represent additional risk for the patient for research purposes. Some patients might
        still require a transplant following VAD treatment. The native heart is removed from these
        patients (routinely discarded) and replaced by a donor heart. The investigators wish to
        utilise this discarded tissue for research purposes, so that the investigators can identify
        the cellular and molecular factors involved in cardiac repair and which distinguish
        responsive and non-responsive patients. Heart transplant recipients who require
        extracorporeal membrane oxygenation will have an additional heart biopsy sample taken for
        research purposes when performed as part of routine clinical practice. There is no additional
        risk to the patient for research purposes. Heart failure patients scheduled for
        transplantation (who have not received a VAD) will be recruited prior to transplantation and
        their native heart retained for research purposes. An additional peripheral blood sample will
        be collected from all patients for research purposes when performed for routine clinical
        practice.
  observational model: Cohort
  time perspective: Prospective
  measure: Changes in protein expression within the tissue during clinical repair.
  time frame: through study completion - 4 years
  description: Relate small changes in protein expression within the heart tissue to clinical parameters indicative of function. Additionally, the investigators aim to extend our understanding of the mechanisms underpinning heart failure by identifying the factors responsible for either preventing repair or promoting expedited disease progression.
  arm group label: Group 1
  description: Heart failure patients requiring ventricular assist device implantation will be included into group 1.
  arm group label: Group 2
  description: Heart transplant recipients requiring early extracorporeal membrane oxygenation will be recruited into group 2.
  arm group label: Group 3
  description: Heart transplant recipients who have not previously received a VAD will be recruited into group 3.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Heart Failure