<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/NCT02254382</url>
  </required_header>
  <id_info>
    <org_study_id>MA130514</org_study_id>
    <nct_id>NCT02254382</nct_id>
  </id_info>
  <brief_title>Positive Airway Pressure Therapy Study in Sleep Apnea and Diastolic Heart Failure</brief_title>
  <acronym>ParadiseHF</acronym>
  <official_title>Positive Airway Pressure Therapy Study in Sleep Apnea and Diastolic Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ResMed</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ResMed</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, prospective, randomized clinical trial (pilot study). 20 participants&#xD;
      with diastolic heart failure will be assigned to ventilation therapy (AutoSet CS ™ ASV&#xD;
      device; therapy group). The trial will run for 6 months, after which change in&#xD;
      echocardiographic parameters of diastolic left ventricular function, sleep and quality of&#xD;
      life parameters will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment rates too low&#xD;
  </why_stopped>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Apnea-Hypopnea-Index (AHI)</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in total sleeping time (TST) determined by parameters of polysomnography</measure>
    <time_frame>6 months</time_frame>
    <description>Total sleeping time (TST) will be measured in minutes (min).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sleep quality determined by parameters of polysomnography</measure>
    <time_frame>6 months</time_frame>
    <description>Sleep Quality will be defined by sleep architecture (time spent in sleep Phase 1,2,3 and REM).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sleep efficacy determined by parameters of polysomnography</measure>
    <time_frame>6 months</time_frame>
    <description>Sleep efficacy is defined as TST/total time spent in bed, i.e. sleep/awake periods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of echocardiographic parameter of diastolic left ventricular ejection fraction function E/è</measure>
    <time_frame>6 months</time_frame>
    <description>E (mitral inflow velocity) and è (mitral annular early diastolic velocity) are parameters to measure filling of the left ventricle with blood.The E/è Ratio gives an estimation of the filling pressure of the left ventricle.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of echocardiographic parameters of diastolic function</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of NYHA stage</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of nocturia</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of questionnaires: ESS</measure>
    <time_frame>6 months</time_frame>
    <description>ESS (Epworth Sleepiness Scale) estimates the sleepiness of a person during daytime.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of questionnaires: MLHFQ</measure>
    <time_frame>6 months</time_frame>
    <description>MLHFQ (Minnesota Living with Heart Failure) estimates how much HF impairs the daily life of a patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of questionnaires (PHQ9)</measure>
    <time_frame>6 months</time_frame>
    <description>PHQ9 (Patient health questionnaire) assesses depression of a patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of questionnaires (SF12HSQ)</measure>
    <time_frame>6 months</time_frame>
    <description>SF12HSQ (short form health status) assesses physical and mental health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in NT-pro BNP and BNP</measure>
    <time_frame>6 months</time_frame>
    <description>NT-pro BNP and BNP (unit ng/l) are comprehensive protein markers of heart diseases, inflammations and cardiovascular disorders. Outcome: Assessment of heart disease status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood gas analysis</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of galactin-3</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 6 minute walk test (MWT)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalisations (reason)</measure>
    <time_frame>6 months</time_frame>
    <description>Reasons will be described in the corresponding files: Type of disease: Treatment related or unrelated?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalisations (cumulative length)</measure>
    <time_frame>6 months</time_frame>
    <description>Length of hospitalizations are measured in days (d). Severity of disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in morning blood pressure</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in morning heart rate</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of Adverse Events (AE) and Serious Adverse Events (SAE)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in parameters of cardiac repolarisation (QT(c), TpTe(c) intervals, TpTe/QT ratio) in ECG at rest</measure>
    <time_frame>6 months</time_frame>
    <description>Electrocardiogram parameters are being put together to assess the patient's heart function status. Outcome: Number of patients with normal heart function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in occurrence of ventricular and supraventricular arrhythmias (PSG-ECG)</measure>
    <time_frame>6 months</time_frame>
    <description>Parameters are being put together to assess the patient's heart function status. Outcome: Number of patients with arrhythmias.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of compliance data</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in spiroergometry data (substudy)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Diastolic Heart Failure</condition>
  <arm_group>
    <arm_group_label>Adaptive servo ventilation (ASV)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive ventilation therapy (AutoSet CS, ASV device)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Adaptive servo ventilation (ASV)</intervention_name>
    <description>Non-invasive Ventilation used to control central and obstructive sleep apnea.</description>
    <arm_group_label>Adaptive servo ventilation (ASV)</arm_group_label>
    <other_name>AutoSet CS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical signs and symptoms of heart failure according to the ESC guidelines&#xD;
&#xD;
          -  Echocardiographic evidence of a preserved systolic left ventricular function&#xD;
             (echocardiographic left ventricular ejection fraction &gt; 50%)&#xD;
&#xD;
          -  Polysomnographic evidence of at least moderate sleep-disordered breathing:&#xD;
             apnea-hypopnea index (AHI) &gt; 15 / h with ≥ 50% central events and with with a central&#xD;
             AHI of ≥ 10/h (AHI based on total sleeping time, TST)&#xD;
&#xD;
          -  BNP or NT-pro BNP ≥ 300 pg / ml&#xD;
&#xD;
          -  NYHA class II or III&#xD;
&#xD;
          -  Patient tolerates the ventilation treatment (1h sample ventilation)&#xD;
&#xD;
          -  Stable drug therapy in the last 4 weeks prior to randomization (no iv diuretic therapy&#xD;
             or increasing the dose of diuretics to ≥ 100%)&#xD;
&#xD;
          -  Minimum age of patients of 18 years&#xD;
&#xD;
          -  patient willing to undergo study procedures&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Oxygen saturation (sO2) &lt;92% of the days in peace without O2 therapy, measured&#xD;
             baseline (start time) in the pulse oximetry or polysomnography in a cape. BGA (the&#xD;
             measurement must be max. Lie back 1 week)&#xD;
&#xD;
          -  Patients, who have a risk professional with symptomatic sleep apnea&#xD;
&#xD;
          -  Known COPD with FEV1 &lt;70%&#xD;
&#xD;
          -  patients with NYHA stadium IV&#xD;
&#xD;
          -  Advanced congenital heart defects&#xD;
&#xD;
          -  pericardial diseases&#xD;
&#xD;
          -  Existing PAP or bi-level therapy (including adaptive servo-ventilation) in the last 3&#xD;
             months&#xD;
&#xD;
          -  Acute cardiac event in the last 3 months&#xD;
&#xD;
          -  BMI ≥ 35kg / m²&#xD;
&#xD;
          -  Pregnant or lactating women&#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>Olaf Oldenburg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Herz- und Diabeteszentrum NRW, Bad Oeynhausen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Regensburg</name>
      <address>
        <city>Regensburg</city>
        <state>Bavaria</state>
        <zip>93053</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart and Diabetes Centre</name>
      <address>
        <city>Bad Oeynhausen</city>
        <state>North Rhine-Westphalia</state>
        <zip>32545</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>April 13, 2017</last_update_submitted>
  <last_update_submitted_qc>April 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diastolic heart failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Heart Failure, Diastolic</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/NCT02254382
org study id: MA130514
nct id: NCT02254382
lead sponsor: 
has dmc: No
This is a multicenter, prospective, randomized clinical trial (pilot study). 20 participants
      with diastolic heart failure will be assigned to ventilation therapy (AutoSet CS ™ ASV
      device; therapy group). The trial will run for 6 months, after which change in
      echocardiographic parameters of diastolic left ventricular function, sleep and quality of
      life parameters will be evaluated.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Apnea-Hypopnea-Index (AHI)
time frame: 6 months
measure: Change in total sleeping time (TST) determined by parameters of polysomnography
time frame: 6 months
description: Total sleeping time (TST) will be measured in minutes (min).
measure: Change in sleep quality determined by parameters of polysomnography
time frame: 6 months
description: Sleep Quality will be defined by sleep architecture (time spent in sleep Phase 1,2,3 and REM).
measure: Change in sleep efficacy determined by parameters of polysomnography
time frame: 6 months
description: Sleep efficacy is defined as TST/total time spent in bed, i.e. sleep/awake periods.
measure: Change of echocardiographic parameter of diastolic left ventricular ejection fraction function E/è
time frame: 6 months
description: E (mitral inflow velocity) and è (mitral annular early diastolic velocity) are parameters to measure filling of the left ventricle with blood.The E/è Ratio gives an estimation of the filling pressure of the left ventricle.
measure: Change of echocardiographic parameters of diastolic function
time frame: 6 months
measure: Change of NYHA stage
time frame: 6 months
measure: Change of nocturia
time frame: 6 months
measure: Changes of questionnaires: ESS
time frame: 6 months
description: ESS (Epworth Sleepiness Scale) estimates the sleepiness of a person during daytime.
measure: Changes of questionnaires: MLHFQ
time frame: 6 months
description: MLHFQ (Minnesota Living with Heart Failure) estimates how much HF impairs the daily life of a patient.
measure: Changes of questionnaires (PHQ9)
time frame: 6 months
description: PHQ9 (Patient health questionnaire) assesses depression of a patient.
measure: Changes of questionnaires (SF12HSQ)
time frame: 6 months
description: SF12HSQ (short form health status) assesses physical and mental health status.
measure: Change in NT-pro BNP and BNP
time frame: 6 months
description: NT-pro BNP and BNP (unit ng/l) are comprehensive protein markers of heart diseases, inflammations and cardiovascular disorders. Outcome: Assessment of heart disease status.
measure: Changes in blood gas analysis
time frame: 6 months
measure: Change of galactin-3
time frame: 6 months
measure: Change in 6 minute walk test (MWT)
time frame: 6 months
measure: Hospitalisations (reason)
time frame: 6 months
description: Reasons will be described in the corresponding files: Type of disease: Treatment related or unrelated?
measure: Hospitalisations (cumulative length)
time frame: 6 months
description: Length of hospitalizations are measured in days (d). Severity of disease.
measure: Change in morning blood pressure
time frame: 6 months
measure: Change in morning heart rate
time frame: 6 months
measure: Occurrence of Adverse Events (AE) and Serious Adverse Events (SAE)
time frame: 6 months
measure: Changes in parameters of cardiac repolarisation (QT(c), TpTe(c) intervals, TpTe/QT ratio) in ECG at rest
time frame: 6 months
description: Electrocardiogram parameters are being put together to assess the patient's heart function status. Outcome: Number of patients with normal heart function.
measure: Changes in occurrence of ventricular and supraventricular arrhythmias (PSG-ECG)
time frame: 6 months
description: Parameters are being put together to assess the patient's heart function status. Outcome: Number of patients with arrhythmias.
measure: Analysis of compliance data
time frame: 6 months
measure: Changes in spiroergometry data (substudy)
time frame: 6 months
arm group label: Adaptive servo ventilation (ASV)
arm group type: Experimental
description: This group will receive ventilation therapy (AutoSet CS, ASV device)
intervention type: Device
intervention name: Adaptive servo ventilation (ASV)
description: Non-invasive Ventilation used to control central and obstructive sleep apnea.
arm group label: Adaptive servo ventilation (ASV)
other name: AutoSet CS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Olaf Oldenburg, MD
role: Principal Investigator
affiliation: Herz- und Diabeteszentrum NRW, Bad Oeynhausen
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Heart Failure, Diastolic