<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/NCT03813511</url>
  </required_header>
  <id_info>
    <org_study_id>HDZ-KA_015_MG</org_study_id>
    <nct_id>NCT03813511</nct_id>
  </id_info>
  <brief_title>Sleep-Disordered Breathing in Patients With Severe Valvular Regurgitation Undergoing Clip Procedure</brief_title>
  <acronym>ClipSDB</acronym>
  <official_title>Prevalence and Dynamics of Sleep-Disordered Breathing (SDB) in Patients With Severe Valvular Regurgitation and High Surgical Risk Undergoing Minimally Invasive Clip Procedure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heart and Diabetes Center North-Rhine Westfalia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Heart and Diabetes Center North-Rhine Westfalia</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>
      In a prospective observational study, the investigators investigate the prevalence of sleep&#xD;
      disordered breathing in patients with severe valvular regurgitation and the effect of using&#xD;
      the minimal invasive Clip technique on sleep disordered breathing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to analyze the prevalance of sleep disordered breathing in&#xD;
      patients with severe valvular regurgitation and the impact of a therapy with the&#xD;
      minimal-invasive Clip technique.&#xD;
&#xD;
      Therefore, the investigators want to include consecutive patients with unknown&#xD;
      sleep-associated respiratory distress syndrome and, in addition, as a study-specific&#xD;
      achievement, the investigators want to obtain the quality of life and specific symptoms of&#xD;
      the patients by using established questionnaires. After three month of post-interventional&#xD;
      care, the patients will get a post-interventional check-up in our cardiological outpatient&#xD;
      clinic, where the course of sleep-associated respiratory distress syndrome and the actual&#xD;
      quality of life and specific symptoms will be documented by using a cardiorespiratory&#xD;
      polygraphy and the same questionnaires.&#xD;
&#xD;
      The entire hospital stay, including possible post-interventional complications, will be&#xD;
      documented for this study from the patients' medical records. The routine examinations&#xD;
      (laboratory values, ECG, 6-minute walk test, pulmonary function examinations, spiroergometry,&#xD;
      transthoracic / -oesophageal echocardiography, etc.) shall also be recorded in the database&#xD;
      of this study.&#xD;
&#xD;
      The plan is to include 100 evaluable patients with complete follow-up and the associated test&#xD;
      results. For this purpose, a screening of 150 patients is expected to be required.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">July 31, 2022</completion_date>
  <primary_completion_date type="Actual">March 14, 2022</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>3 Months</target_duration>
  <primary_outcome>
    <measure>Prevalance of Sleep disordered breathing in Patiens with severe valvular regurgitation</measure>
    <time_frame>3 month</time_frame>
    <description>Proportion of of Sleep disordered breathing in Patiens with severe valvular regurgitation in a given time period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Influence of the minimal invasive Clip technique on apnea-hypopnea index</measure>
    <time_frame>3 month</time_frame>
    <description>Changes on the number of apnea and hypopnea events per hour of sleep due to the minimal invasiv Clip technique</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Influence of the minimal invasive Clip technique on apnea index</measure>
    <time_frame>3 month</time_frame>
    <description>Changes on the number of apnea events per hour of sleep due to the minimal invasiv Clip technique</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Influence of the minimal invasive Clip technique on the oxygen desaturation index</measure>
    <time_frame>3 month</time_frame>
    <description>Changes on the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline due to the minimal invasiv Clip technique</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Influence of the minimal invasive Clip technique on T90</measure>
    <time_frame>3 month</time_frame>
    <description>Changes on the the percentage of time during which arterial O2 saturation was less than 90% (T90) due to the minimal invasiv Clip technique</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Influence of the minimal invasive Clip technique on sleep cycle length</measure>
    <time_frame>3 month</time_frame>
    <description>Changes on the duration of the five stages of sleep (in minutes) due to the minimal invasiv Clip technique</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Influence of the minimal invasive Clip technique on ventilation length during sleep</measure>
    <time_frame>3 month</time_frame>
    <description>Changes on the ventilation length (in seconds) due to the minimal invasiv Clip technique</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Influence of the minimal invasive Clip technique on PISA in tranthoracic echocardiography</measure>
    <time_frame>3 month</time_frame>
    <description>Changes on the proximal isovelocity hemispheric surface area (PISA in square millimeter) in tranthoracic echocardiography due to the minimal invasiv Clip technique</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Influence of the minimal invasive Clip technique on the effective regurgitant orifice (ERO) in tranthoracic echocardiography</measure>
    <time_frame>3 month</time_frame>
    <description>Changes on the effective regurgitant orifice (ERO in square millimeter) in tranthoracic echocardiography due to the minimal invasiv Clip technique</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Influence of the minimal invasive Clip technique on the peak velocity of the mitral regurgitant jet (mR-Vmax) in tranthoracic echocardiography</measure>
    <time_frame>3 month</time_frame>
    <description>Changes on the peak velocity of the mitral regurgitant jet (mR-Vmax in meter per seconds) in tranthoracic echocardiography due to the minimal invasiv Clip technique</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Influence of the minimal invasive Clip technique on the myocardial perfomance index (TEI-index) in tranthoracic echocardiography</measure>
    <time_frame>3 month</time_frame>
    <description>Changes on systolic and diastolic time intervals in expressing global systolic and diastolic ventricular function (without unity) in tranthoracic echocardiography due to the minimal invasiv Clip technique</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-interventional changes in daytime sleepiness with and without sleep disordered breathing</measure>
    <time_frame>3 month</time_frame>
    <description>Post-interventional changes in daytime sleepiness with and without sleep disordered breathing measured by the Epworth Sleepinss Scale (ESS) (From 0 to 24 point-scale; A number in the 0-9 range is considered to be normal while a number in the 10-24 range indicates severe daytime sleepiness)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-interventional survey of patient health with and without sleep disordered breathing</measure>
    <time_frame>3 month</time_frame>
    <description>Post-interventional survey of patient health with and without sleep disordered breathing measured by the Short Form (36) Health Survey (SF-36).&#xD;
SF-36 consists of eight scaled score (Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health). Total range from 0 to 100 points (from worst to best)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-interventional assesment of Symptoms, function and quallity of life with and without sleep disordered breathing by patients with heart failure</measure>
    <time_frame>3 month</time_frame>
    <description>Post-interventional assesment of Symptoms, function and quallity of life with and without sleep disordered breathing by patients with heart failure using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) that hat quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Total range is from 0 to 100 points. 0 denotes the worst and 100 the best possible health status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-interventional measurement of the adverse effects of heart failure on patient's life with and without sleep disordered breathing</measure>
    <time_frame>3 month</time_frame>
    <description>Post-interventional measurement of the adverse effects of heart failure on patient's life with and without sleep disordered breathing using the Minnesota Living with Heart Failure Questionnaire. It provides a total score range 0-105, from best to worst</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-interventional assessment of the sleep quality with and without sleep disordered breathing</measure>
    <time_frame>3 month</time_frame>
    <description>Post-interventional assessment of the sleep quality with and without sleep disordered breathing using the Pittsburgh Sleep Quality Index (PSQI) (From 0 (worst) to 21 (best))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-interventional changes in generic health status. with and without sleep disordered breathing</measure>
    <time_frame>3 month</time_frame>
    <description>Post-interventional changes in generic health status. with and without sleep disordered breathing using the EQ-5D questionnaire (grade ranging from 0, the worst possible health status, to 100 ,the best possible health status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-interventional changes aerobic capacity and endurance with and without sleep disordered breathing</measure>
    <time_frame>3 month</time_frame>
    <description>Post-interventional changes on aerobic capacity and endurance with and without sleep disordered breathing using the cardiopulmonary exercise testing (vO2max in milliliter per minute per kilogram</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-interventional changes functional capacity of cardiopulmonary and musculoskeletal system with and without sleep disordered breathing</measure>
    <time_frame>3 month</time_frame>
    <description>Post-interventional changes on aerobic capacity and endurance with and without sleep disordered breathing using the six minutes walk test (in meters)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-interventional changes on cognitive functions with and without sleep disordered breathing</measure>
    <time_frame>3 month</time_frame>
    <description>Post-interventional changes on cognitive functions with and without sleep disordered breathing using the Montreal Cognitive Assessment Test (MOCA) (From 0 (worst) to 30 (best) point-scale)</description>
  </secondary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Sleep Disordered Breathing</condition>
  <condition>Valvular Regurgitation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Stationäre patients with severe valvular regurgitation and currently unknown sleep disorder&#xD;
        breathing who will be treated with a minimal invasive Clip technique&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with severe valvular regurgitation and currently unknown sleep disorder&#xD;
             breathing who will be treated with a minimal invasive Clip technique&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with more then one valvular disease which requires Treatment&#xD;
&#xD;
          -  Patients with complex congenital heart disease&#xD;
&#xD;
          -  Pregnant 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>Muhammed Gercek, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Heart and Diabetes Center North Rhine-Westphalia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum</name>
      <address>
        <city>Bad Oeynhausen</city>
        <zip>32545</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 19, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>March 3, 2023</last_update_submitted>
  <last_update_submitted_qc>March 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2023</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>Muhammed Gerçek</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Minimally invasive surgery</keyword>
  <keyword>Clip procedure</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>
  </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/NCT03813511
org study id: HDZ-KA_015_MG
nct id: NCT03813511
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In a prospective observational study, the investigators investigate the prevalence of sleep
      disordered breathing in patients with severe valvular regurgitation and the effect of using
      the minimal invasive Clip technique on sleep disordered breathing.
The purpose of this study is to analyze the prevalance of sleep disordered breathing in
      patients with severe valvular regurgitation and the impact of a therapy with the
      minimal-invasive Clip technique.

      Therefore, the investigators want to include consecutive patients with unknown
      sleep-associated respiratory distress syndrome and, in addition, as a study-specific
      achievement, the investigators want to obtain the quality of life and specific symptoms of
      the patients by using established questionnaires. After three month of post-interventional
      care, the patients will get a post-interventional check-up in our cardiological outpatient
      clinic, where the course of sleep-associated respiratory distress syndrome and the actual
      quality of life and specific symptoms will be documented by using a cardiorespiratory
      polygraphy and the same questionnaires.

      The entire hospital stay, including possible post-interventional complications, will be
      documented for this study from the patients' medical records. The routine examinations
      (laboratory values, ECG, 6-minute walk test, pulmonary function examinations, spiroergometry,
      transthoracic / -oesophageal echocardiography, etc.) shall also be recorded in the database
      of this study.

      The plan is to include 100 evaluable patients with complete follow-up and the associated test
      results. For this purpose, a screening of 150 patients is expected to be required.
observational model: Cohort
time perspective: Prospective
measure: Prevalance of Sleep disordered breathing in Patiens with severe valvular regurgitation
time frame: 3 month
description: Proportion of of Sleep disordered breathing in Patiens with severe valvular regurgitation in a given time period
measure: Influence of the minimal invasive Clip technique on apnea-hypopnea index
time frame: 3 month
description: Changes on the number of apnea and hypopnea events per hour of sleep due to the minimal invasiv Clip technique
measure: Influence of the minimal invasive Clip technique on apnea index
time frame: 3 month
description: Changes on the number of apnea events per hour of sleep due to the minimal invasiv Clip technique
measure: Influence of the minimal invasive Clip technique on the oxygen desaturation index
time frame: 3 month
description: Changes on the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline due to the minimal invasiv Clip technique
measure: Influence of the minimal invasive Clip technique on T90
time frame: 3 month
description: Changes on the the percentage of time during which arterial O2 saturation was less than 90% (T90) due to the minimal invasiv Clip technique
measure: Influence of the minimal invasive Clip technique on sleep cycle length
time frame: 3 month
description: Changes on the duration of the five stages of sleep (in minutes) due to the minimal invasiv Clip technique
measure: Influence of the minimal invasive Clip technique on ventilation length during sleep
time frame: 3 month
description: Changes on the ventilation length (in seconds) due to the minimal invasiv Clip technique
measure: Influence of the minimal invasive Clip technique on PISA in tranthoracic echocardiography
time frame: 3 month
description: Changes on the proximal isovelocity hemispheric surface area (PISA in square millimeter) in tranthoracic echocardiography due to the minimal invasiv Clip technique
measure: Influence of the minimal invasive Clip technique on the effective regurgitant orifice (ERO) in tranthoracic echocardiography
time frame: 3 month
description: Changes on the effective regurgitant orifice (ERO in square millimeter) in tranthoracic echocardiography due to the minimal invasiv Clip technique
measure: Influence of the minimal invasive Clip technique on the peak velocity of the mitral regurgitant jet (mR-Vmax) in tranthoracic echocardiography
time frame: 3 month
description: Changes on the peak velocity of the mitral regurgitant jet (mR-Vmax in meter per seconds) in tranthoracic echocardiography due to the minimal invasiv Clip technique
measure: Influence of the minimal invasive Clip technique on the myocardial perfomance index (TEI-index) in tranthoracic echocardiography
time frame: 3 month
description: Changes on systolic and diastolic time intervals in expressing global systolic and diastolic ventricular function (without unity) in tranthoracic echocardiography due to the minimal invasiv Clip technique
measure: Post-interventional changes in daytime sleepiness with and without sleep disordered breathing
time frame: 3 month
description: Post-interventional changes in daytime sleepiness with and without sleep disordered breathing measured by the Epworth Sleepinss Scale (ESS) (From 0 to 24 point-scale; A number in the 0-9 range is considered to be normal while a number in the 10-24 range indicates severe daytime sleepiness)
measure: Post-interventional survey of patient health with and without sleep disordered breathing
time frame: 3 month
description: Post-interventional survey of patient health with and without sleep disordered breathing measured by the Short Form (36) Health Survey (SF-36).
SF-36 consists of eight scaled score (Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health). Total range from 0 to 100 points (from worst to best)
measure: Post-interventional assesment of Symptoms, function and quallity of life with and without sleep disordered breathing by patients with heart failure
time frame: 3 month
description: Post-interventional assesment of Symptoms, function and quallity of life with and without sleep disordered breathing by patients with heart failure using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) that hat quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Total range is from 0 to 100 points. 0 denotes the worst and 100 the best possible health status
measure: Post-interventional measurement of the adverse effects of heart failure on patient's life with and without sleep disordered breathing
time frame: 3 month
description: Post-interventional measurement of the adverse effects of heart failure on patient's life with and without sleep disordered breathing using the Minnesota Living with Heart Failure Questionnaire. It provides a total score range 0-105, from best to worst
measure: Post-interventional assessment of the sleep quality with and without sleep disordered breathing
time frame: 3 month
description: Post-interventional assessment of the sleep quality with and without sleep disordered breathing using the Pittsburgh Sleep Quality Index (PSQI) (From 0 (worst) to 21 (best))
measure: Post-interventional changes in generic health status. with and without sleep disordered breathing
time frame: 3 month
description: Post-interventional changes in generic health status. with and without sleep disordered breathing using the EQ-5D questionnaire (grade ranging from 0, the worst possible health status, to 100 ,the best possible health status
measure: Post-interventional changes aerobic capacity and endurance with and without sleep disordered breathing
time frame: 3 month
description: Post-interventional changes on aerobic capacity and endurance with and without sleep disordered breathing using the cardiopulmonary exercise testing (vO2max in milliliter per minute per kilogram
measure: Post-interventional changes functional capacity of cardiopulmonary and musculoskeletal system with and without sleep disordered breathing
time frame: 3 month
description: Post-interventional changes on aerobic capacity and endurance with and without sleep disordered breathing using the six minutes walk test (in meters)
measure: Post-interventional changes on cognitive functions with and without sleep disordered breathing
time frame: 3 month
description: Post-interventional changes on cognitive functions with and without sleep disordered breathing using the Montreal Cognitive Assessment Test (MOCA) (From 0 (worst) to 30 (best) point-scale)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Muhammed Gercek, MD
role: Principal Investigator
affiliation: Heart and Diabetes Center North Rhine-Westphalia
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Heart and Diabetes Center North-Rhine Westfalia
investigator full name: Muhammed Gerçek
investigator title: Principal Investigator
mesh term: Respiratory Aspiration
mesh term: Sleep Apnea Syndromes
sharing ipd: No