<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/NCT03026634</url>
  </required_header>
  <id_info>
    <org_study_id>PDSAP-HTX</org_study_id>
    <nct_id>NCT03026634</nct_id>
  </id_info>
  <brief_title>Prevalence and Dynamic of Sleep-disordered Breathing in Patients Pre and Post Heart Transplantation</brief_title>
  <acronym>HTx-HDZ-SDB-1</acronym>
  <official_title>Prevalence and Dynamic of Sleep-disordered Breathing in Patients Pre and Post Heart Transplantation - a Prospective Single Center Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heart and Diabetes Center North-Rhine Westfalia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Deutsche Herzstiftung e.V.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Deutsche Stiftung für Herzforschung</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Heart and Diabetes Center North-Rhine Westfalia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sleep-disordered breathing is believed to appear at a high prevalence in end-stage heart&#xD;
      failure patients and the presence of sleep-disordered breathing has been associated with&#xD;
      increased mortality. This study is designed to investigate prevalence and dynamics of&#xD;
      sleep-disordered breathing in end-stage heart failure patients pre and post heart&#xD;
      transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sleep-disordered breathing is believed to appear at a high prevalence in end-stage heart&#xD;
      failure patients and the presence of sleep-disordered breathing has been associated with&#xD;
      increased mortality. This study is designed to investigate prevalence and dynamics of&#xD;
      sleep-disordered breathing in end-stage heart failure patients pre and post heart&#xD;
      transplantation, as this topic is hardly studied yet and previous reports suggest changes in&#xD;
      the entity of sleep-disordered breathing through heart transplantation. The circumstances and&#xD;
      the impact of sleep-disordered breathing or residuals in heart transplant patients is not&#xD;
      well understood yet and will be subject of this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">October 9, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Month</target_duration>
  <primary_outcome>
    <measure>Apnea Hypopnea Index</measure>
    <time_frame>30 days after heart transplantation</time_frame>
    <description>Change in Apnea Hypopnea Index (AHI /h) before and after heart transplantation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Apnea Index</measure>
    <time_frame>30 days after heart transplantation</time_frame>
    <description>Change in Apnea Index (AI /h) before and after heart transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypopnea Index</measure>
    <time_frame>30 days after heart transplantation</time_frame>
    <description>Change in Hypopnea Index (HI /h) before and after heart transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen Desaturation Index</measure>
    <time_frame>30 days after heart transplantation</time_frame>
    <description>Change in Oxygen Desaturation (ODI /h) before and after heart transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time SaO2 &lt; 90 (%)</measure>
    <time_frame>30 days after heart transplantation</time_frame>
    <description>Change in Time SaO2 &lt; 90 (%) before and after heart transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiration cycle length</measure>
    <time_frame>30 days after heart transplantation</time_frame>
    <description>Change in Respiration cycle lengths before and after heart transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Questionnaires</measure>
    <time_frame>30 days after heart transplantation</time_frame>
    <description>Change in MLWH questionnaire, this questionnaires obtains patient's quality of life in a score (in points)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Questionnaires</measure>
    <time_frame>30 days after heart transplantation</time_frame>
    <description>ESS questionnaire, this questionnaires obtains patient's sleepiness in daily life in a score (in points)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Questionnaires</measure>
    <time_frame>30 days after heart transplantation</time_frame>
    <description>Short Form 12 Health Survey Questionnaire, this questionnaires obtains patient's health status in a score (in points)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right heart catheter</measure>
    <time_frame>30 days after heart transplantation</time_frame>
    <description>Changes in right heart catheter before and after heart transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood gas analysis</measure>
    <time_frame>30 days after heart transplantation</time_frame>
    <description>Changes in blood gas analyses before and after heart transplantation</description>
  </secondary_outcome>
  <enrollment type="Actual">500</enrollment>
  <condition>Sleep Disordered Breathing Central</condition>
  <condition>Heart Failure</condition>
  <condition>Heart Transplantation</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep-disordered breathing</intervention_name>
    <description>Prevalence and dynamic of sleep-disordered breathing after heart transplantation</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      plasma, serum and urine samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        End-stage heart failure patients assigned and eligible for heart transplantation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  End-stage heart failure patients assigned and eligible for heart transplantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  heart failure patients not eligible for heart transplantation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Herz- und Diabeteszentrum NRW</name>
      <address>
        <city>Bad Oeynhausen</city>
        <state>NRW</state>
        <zip>32545</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <results_reference>
    <citation>Fox H, Puehler T, Schulz U, Bitter T, Horstkotte D, Oldenburg O. Delayed recovery from Cheyne-Stokes respiration in heart failure after successful cardiac transplantation: a case report. Transplant Proc. 2014 Sep;46(7):2462-3. doi: 10.1016/j.transproceed.2014.06.063.</citation>
    <PMID>25242802</PMID>
  </results_reference>
  <results_reference>
    <citation>Basic K, Fox H, Spiesshofer J, Bitter T, Horstkotte D, Oldenburg O. Improvements of central respiratory events, Cheyne-Stokes respiration and oxygenation in patients hospitalized for acute decompensated heart failure. Sleep Med. 2016 Nov-Dec;27-28:15-19. doi: 10.1016/j.sleep.2016.10.006. Epub 2016 Oct 28.</citation>
    <PMID>27938912</PMID>
  </results_reference>
  <results_reference>
    <citation>Oldenburg O, Wellmann B, Buchholz A, Bitter T, Fox H, Thiem U, Horstkotte D, Wegscheider K. Nocturnal hypoxaemia is associated with increased mortality in stable heart failure patients. Eur Heart J. 2016 Jun 1;37(21):1695-703. doi: 10.1093/eurheartj/ehv624. Epub 2015 Nov 26.</citation>
    <PMID>26612581</PMID>
  </results_reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>May 5, 2021</last_update_submitted>
  <last_update_submitted_qc>May 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Heart and Diabetes Center North-Rhine Westfalia</investigator_affiliation>
    <investigator_full_name>Henrik Fox, MD</investigator_full_name>
    <investigator_title>Cardiologist</investigator_title>
  </responsible_party>
  <keyword>Sleep-Disordered Breathing</keyword>
  <keyword>Heart Failure</keyword>
  <keyword>Heart Transplantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Heart Failure</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/NCT03026634
org study id: PDSAP-HTX
nct id: NCT03026634
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Sleep-disordered breathing is believed to appear at a high prevalence in end-stage heart
      failure patients and the presence of sleep-disordered breathing has been associated with
      increased mortality. This study is designed to investigate prevalence and dynamics of
      sleep-disordered breathing in end-stage heart failure patients pre and post heart
      transplantation.
Sleep-disordered breathing is believed to appear at a high prevalence in end-stage heart
      failure patients and the presence of sleep-disordered breathing has been associated with
      increased mortality. This study is designed to investigate prevalence and dynamics of
      sleep-disordered breathing in end-stage heart failure patients pre and post heart
      transplantation, as this topic is hardly studied yet and previous reports suggest changes in
      the entity of sleep-disordered breathing through heart transplantation. The circumstances and
      the impact of sleep-disordered breathing or residuals in heart transplant patients is not
      well understood yet and will be subject of this study.
observational model: Cohort
time perspective: Prospective
measure: Apnea Hypopnea Index
time frame: 30 days after heart transplantation
description: Change in Apnea Hypopnea Index (AHI /h) before and after heart transplantation
measure: Apnea Index
time frame: 30 days after heart transplantation
description: Change in Apnea Index (AI /h) before and after heart transplantation
measure: Hypopnea Index
time frame: 30 days after heart transplantation
description: Change in Hypopnea Index (HI /h) before and after heart transplantation
measure: Oxygen Desaturation Index
time frame: 30 days after heart transplantation
description: Change in Oxygen Desaturation (ODI /h) before and after heart transplantation
measure: Time SaO2 < 90 (%)
time frame: 30 days after heart transplantation
description: Change in Time SaO2 < 90 (%) before and after heart transplantation
measure: Respiration cycle length
time frame: 30 days after heart transplantation
description: Change in Respiration cycle lengths before and after heart transplantation
measure: Health Questionnaires
time frame: 30 days after heart transplantation
description: Change in MLWH questionnaire, this questionnaires obtains patient's quality of life in a score (in points)
measure: Health Questionnaires
time frame: 30 days after heart transplantation
description: ESS questionnaire, this questionnaires obtains patient's sleepiness in daily life in a score (in points)
measure: Health Questionnaires
time frame: 30 days after heart transplantation
description: Short Form 12 Health Survey Questionnaire, this questionnaires obtains patient's health status in a score (in points)
measure: Right heart catheter
time frame: 30 days after heart transplantation
description: Changes in right heart catheter before and after heart transplantation
measure: Blood gas analysis
time frame: 30 days after heart transplantation
description: Changes in blood gas analyses before and after heart transplantation
intervention type: Behavioral
intervention name: Sleep-disordered breathing
description: Prevalence and dynamic of sleep-disordered breathing after heart transplantation
plasma, serum and urine samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Germany
citation: Fox H, Puehler T, Schulz U, Bitter T, Horstkotte D, Oldenburg O. Delayed recovery from Cheyne-Stokes respiration in heart failure after successful cardiac transplantation: a case report. Transplant Proc. 2014 Sep;46(7):2462-3. doi: 10.1016/j.transproceed.2014.06.063.
PMID: 25242802
citation: Basic K, Fox H, Spiesshofer J, Bitter T, Horstkotte D, Oldenburg O. Improvements of central respiratory events, Cheyne-Stokes respiration and oxygenation in patients hospitalized for acute decompensated heart failure. Sleep Med. 2016 Nov-Dec;27-28:15-19. doi: 10.1016/j.sleep.2016.10.006. Epub 2016 Oct 28.
PMID: 27938912
citation: Oldenburg O, Wellmann B, Buchholz A, Bitter T, Fox H, Thiem U, Horstkotte D, Wegscheider K. Nocturnal hypoxaemia is associated with increased mortality in stable heart failure patients. Eur Heart J. 2016 Jun 1;37(21):1695-703. doi: 10.1093/eurheartj/ehv624. Epub 2015 Nov 26.
PMID: 26612581
responsible party type: Principal Investigator
investigator affiliation: Heart and Diabetes Center North-Rhine Westfalia
investigator full name: Henrik Fox, MD
investigator title: Cardiologist
mesh term: Respiratory Aspiration
mesh term: Sleep Apnea Syndromes
mesh term: Heart Failure
sharing ipd: No