<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/NCT04423562</url>
  </required_header>
  <id_info>
    <org_study_id>330131365/2</org_study_id>
    <nct_id>NCT04423562</nct_id>
  </id_info>
  <brief_title>PROgnostic Value of Exercise Capacity Measured as Peak Oxygen Uptake (pVO2) in Recipients of Left Ventricular Assist Devices</brief_title>
  <acronym>PRO-VAD</acronym>
  <official_title>Investigation of the Prognostic Value of pVO2 in Recipients of Left Ventricular Assist Devices</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</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>
      Pooling of earlier VO2-studies conducted at the dept. of cardiology, Rigshospitalet, Denmark,&#xD;
      and all LVAD centres of the World that wish to participate.&#xD;
&#xD;
      The purpose is to investigate the prognostic value of VO2 in recipients of durable LVADs&#xD;
      using data from studies already conducted.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background and purpose:&#xD;
&#xD;
      Peak oxygen uptake (pVO2) is used extensively in HF to predict prognosis and time for heart&#xD;
      transplantation. Many centers are increasingly measuring pVO2 in LVAD supported HF patients,&#xD;
      though this has mostly been for research or rehabilitation purposes. It is unknown if pVO2&#xD;
      predicts outcome in LVAD treated HF patients.&#xD;
&#xD;
      The investigators will pool data from all willing centers of the World to investigate the&#xD;
      prognostic value of pVO2 (e.g. outcome in LVAD supported patients) and, secondly the&#xD;
      investigators will investigate wether the predictive power of pVO2 in LVAD recipients depends&#xD;
      on the treatment indication (BTT and DT).&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Data is collected in anonymized form from all centers willing to contribute data.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      The hypothesis is that lower pVO2 is associated with higher rates of death or urgent&#xD;
      transplantation (primary endpoint).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 10, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Outcome after implantation</measure>
    <time_frame>Stable-phase post implant VO2 (e.g. &gt;3months and up to 13 year post implant)</time_frame>
    <description>Survival/ongiong on device/explant/htx after LVAD implantation</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Left Ventricular Assist Device</condition>
  <condition>Prognosis</condition>
  <condition>Advanced Heart Failure</condition>
  <arm_group>
    <arm_group_label>Durable LVAD recipient with post implant VO2</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention</description>
    <arm_group_label>Durable LVAD recipient with post implant VO2</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients implanted with a durable LVAD (post-2006) and available post implant VO2&#xD;
        (stable phase) can be included in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Durable LVAD implantation&#xD;
&#xD;
          -  VO2 in stable post implant phase&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No VO2 data available&#xD;
&#xD;
          -  Concomittant RVAD (temp/durable device)&#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_official>
    <last_name>Finn Gustafsson, MD,PhD,DMSci</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rigshospitalet, Denmark</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kiran Mirza, MD</last_name>
    <phone>+4531679333</phone>
    <email>KiranMirza@dadlnet.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Finn Gustafsson, MD, PhD, DMSci</last_name>
    <phone>+4535459743</phone>
    <email>Finn.Gustafsson@regionh.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <state>DK</state>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kiran Mirza, MD</last_name>
      <phone>+4535451442</phone>
      <email>KiranMirza@dadlnet.dk</email>
    </contact>
    <contact_backup>
      <last_name>Finn Gustafsson, MD,PhD,DMSc.</last_name>
      <phone>+4535459743</phone>
      <email>Finn.Gustafsson@regionh.dk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 7, 2020</last_update_submitted>
  <last_update_submitted_qc>June 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Finn Gustafsson</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04423562
org study id: 330131365/2
nct id: NCT04423562
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pooling of earlier VO2-studies conducted at the dept. of cardiology, Rigshospitalet, Denmark,
      and all LVAD centres of the World that wish to participate.

      The purpose is to investigate the prognostic value of VO2 in recipients of durable LVADs
      using data from studies already conducted.
Background and purpose:

      Peak oxygen uptake (pVO2) is used extensively in HF to predict prognosis and time for heart
      transplantation. Many centers are increasingly measuring pVO2 in LVAD supported HF patients,
      though this has mostly been for research or rehabilitation purposes. It is unknown if pVO2
      predicts outcome in LVAD treated HF patients.

      The investigators will pool data from all willing centers of the World to investigate the
      prognostic value of pVO2 (e.g. outcome in LVAD supported patients) and, secondly the
      investigators will investigate wether the predictive power of pVO2 in LVAD recipients depends
      on the treatment indication (BTT and DT).

      Methods:

      Data is collected in anonymized form from all centers willing to contribute data.

      Hypothesis:

      The hypothesis is that lower pVO2 is associated with higher rates of death or urgent
      transplantation (primary endpoint).
observational model: Cohort
time perspective: Retrospective
measure: Outcome after implantation
time frame: Stable-phase post implant VO2 (e.g. >3months and up to 13 year post implant)
description: Survival/ongiong on device/explant/htx after LVAD implantation
arm group label: Durable LVAD recipient with post implant VO2
intervention type: Other
intervention name: No intervention
description: No intervention
arm group label: Durable LVAD recipient with post implant VO2
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Finn Gustafsson, MD,PhD,DMSci
role: Principal Investigator
affiliation: Rigshospitalet, Denmark
last name: Kiran Mirza, MD
phone: +4531679333
email: KiranMirza@dadlnet.dk
last name: Finn Gustafsson, MD, PhD, DMSci
phone: +4535459743
email: Finn.Gustafsson@regionh.dk
facility: 
status: Recruiting
contact: 
contact backup: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Finn Gustafsson
investigator title: Professor
mesh term: Heart Failure
sharing ipd: Undecided