<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/NCT02989181</url>
  </required_header>
  <id_info>
    <org_study_id>FoU127221</org_study_id>
    <nct_id>NCT02989181</nct_id>
  </id_info>
  <brief_title>Continues Positive Airway Pressure Treatment for Patients With Dilated Cardiomyopathy and Obstructive Sleep Apnea</brief_title>
  <acronym>RIDA</acronym>
  <official_title>Impact of Continues Positive Airway Pressure Treatment in Patients With Dilated Cardiomyopathy and Obstructive Sleep Apnea (RIDA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Göteborg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Göteborg University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this randomized controlled study is to investigate the effect of continues&#xD;
      positive airway pressure (CPAP) treatment in patients with dilated cardiomyopathy (DCM) and&#xD;
      concomitant obstructive sleep apnea (OSA). The primary endpoint is left ventricular function&#xD;
      measured by magnetic resonance (improvement of at least 4%) after six months treatment with&#xD;
      CPAP.&#xD;
&#xD;
      The secondary endpoints include diastolic dysfunction, cardiovascular biomarkers and quality&#xD;
      of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sleep apnea, either obstructive (OSA) and central (CSA), occurs in more than half of all&#xD;
      patients with heart failure (HF), and is associated with poor prognosis in these individuals.&#xD;
&#xD;
      Dilated cardiomyopathy (DCM) is the most common type of cardiomyopathy and is defined as the&#xD;
      presence of the left ventricle dilatation and left ventricular systolic dysfunction without&#xD;
      concurrent valvular or coronary artery disease. Its etiology is unclear, but a genetic&#xD;
      component is present in at least 25% of cases. In younger individuals, the etiology is more&#xD;
      heterogeneous, where a rare type of cardiomyopathy may occur in women in connection with&#xD;
      pregnancy, s.c. peripartum cardiomyopathy. Other underlying causes include alcohol, drugs,&#xD;
      pharmaceuticals, endocrine disorders, systemic diseases and general muscle. These factors&#xD;
      account for approximately half the cases of DCM in younger and other half designated as&#xD;
      idiopathic (IDCM).&#xD;
&#xD;
      The relationship between cardiomyopathies and OSA is insufficiently studied so far. In a&#xD;
      smaller population of 20 individuals with DCM, sleep apnea (OSA or CSA) had 16, ie 80% of&#xD;
      patients. The first-line treatment of OSA is continues positive pressure breathing mask&#xD;
      (CPAP) during sleep in patients with daytime sleepiness. Effect of CPAP therapy in patients&#xD;
      with DCM and OSA is completely unknown, because many of them do not report daytime&#xD;
      sleepiness. The fact that patients with heart failure and reduced pumping function usually&#xD;
      have symptoms of including fatigue, it becomes difficult to distinguish what is fatigue due&#xD;
      to heart failure and what is related to sleep apnea. Interpretation of the Epworth Sleepiness&#xD;
      Scale (ESS) is thus difficult and possibly unsure why all patients with DCM and OSA will be&#xD;
      randomized to treatment with CPAP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2014</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in left ventricular ejection fraction (LVEF) six months after randomization to Continues Positive Airway Pressure (CPAP) treatment or consultation of conservative measures</measure>
    <time_frame>6 months</time_frame>
    <description>The primary endpoint is left ventricular ejection fraction (LVEF) measured by cardiac magnetic resonance (improvement of at least 4%) at study baseline and at 6 months after randomization to Continues Positive Airway Pressure (CPAP) or consultation of conservative measures.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in left ventricular ejection fraction (LVEF) six months after randomization to Continues Positive Airway Pressure (CPAP) treatment or consultation of conservative measures</measure>
    <time_frame>6 months</time_frame>
    <description>The primary endpoint is left ventricular ejection fraction (LVEF) measured by echocardiography at study baseline and at 6 months after randomization to Continues Positive Airway Pressure (CPAP) or consultation of conservative measures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in measurements of diastolic function after randomization to Continues Positive Airway Pressure (CPAP) or consultation of conservative measures.</measure>
    <time_frame>baseline and at six months</time_frame>
    <description>Secondary outcomes include measurements of diastolic function measured by cardiac magnetic resonance (CMR) and echocardiography,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in measurements of cardiovascular biomarkers at</measure>
    <time_frame>baseline and at six months</time_frame>
    <description>Analyzing change in cardiovascular biomarkers by analyzing blood samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life questioners</measure>
    <time_frame>baseline and at six months</time_frame>
    <description>Analyzing participants response to quality of life by analyzing established questioners regarding dilated cardiomyopathy (Kansas city cardiomyopathy questionnaire KCCQ).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in day-time sleepiness</measure>
    <time_frame>baseline and at six month</time_frame>
    <description>Analyzing participants respons to established questioners regarding sleep apnea (Epworth sleepiness scale ESS) and</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">44</enrollment>
  <condition>Dilated Cardiomyopathy</condition>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Continues Positive Airway Pressure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of Continues Positive Airway Pressure (CPAP) mask every night under six months period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Consultation of conservative measures</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Study participants with DCM and OSA (no-CPAP), participants receive consultation of conservative measures such as avoiding alcohol before bedrest, sleeping on the side...</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continues Positive Airway Pressure (CPAP)</intervention_name>
    <description>Mask with positive airway pressure during exhalation which maintains the airway open</description>
    <arm_group_label>Continues Positive Airway Pressure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with newly diagnosed or previously known DCM, treated and followed at cardiology&#xD;
        outpatients clinic, stable in their symptoms and functional class at least 2 weeks after&#xD;
        the last medicine change.&#xD;
&#xD;
          -  Consent for the study.&#xD;
&#xD;
          -  EF ≤ 45%.&#xD;
&#xD;
          -  OSA diagnosis (Apnea-Hypopnea index&gt; = 15 in the sleep recording below).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients already treated with Continues Positive Airway Pressure.&#xD;
&#xD;
          -  Patients with claustrophobia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Maria Schaufelberger, Associate Professor</last_name>
    <phone>+46313434085</phone>
    <email>maria.schaufelberger@gu.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Carmen Basic, MD</last_name>
    <phone>+46704807426</phone>
    <email>carmen.basic@gu.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sahlgrenska University Hospital/Östra</name>
      <address>
        <city>Gothenburg</city>
        <zip>41678</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Schaufelberger, Assoc.Prof.</last_name>
      <phone>+46313434085</phone>
      <email>maria.schaufelberger@gu.se</email>
    </contact>
    <contact_backup>
      <last_name>Carmen Basic, MD</last_name>
      <phone>+46704807426</phone>
      <email>carmen.basic@gu.se</email>
    </contact_backup>
    <investigator>
      <last_name>Erik Thunström, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yuksel Peker, Professor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>March 6, 2018</last_update_submitted>
  <last_update_submitted_qc>March 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Göteborg University</investigator_affiliation>
    <investigator_full_name>Maria Schaufelberger</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    <mesh_term>Cardiomyopathies</mesh_term>
    <mesh_term>Cardiomyopathy, Dilated</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/NCT02989181
org study id: FoU127221
nct id: NCT02989181
lead sponsor: 
has dmc: Yes
The aim of this randomized controlled study is to investigate the effect of continues
      positive airway pressure (CPAP) treatment in patients with dilated cardiomyopathy (DCM) and
      concomitant obstructive sleep apnea (OSA). The primary endpoint is left ventricular function
      measured by magnetic resonance (improvement of at least 4%) after six months treatment with
      CPAP.

      The secondary endpoints include diastolic dysfunction, cardiovascular biomarkers and quality
      of life.
Sleep apnea, either obstructive (OSA) and central (CSA), occurs in more than half of all
      patients with heart failure (HF), and is associated with poor prognosis in these individuals.

      Dilated cardiomyopathy (DCM) is the most common type of cardiomyopathy and is defined as the
      presence of the left ventricle dilatation and left ventricular systolic dysfunction without
      concurrent valvular or coronary artery disease. Its etiology is unclear, but a genetic
      component is present in at least 25% of cases. In younger individuals, the etiology is more
      heterogeneous, where a rare type of cardiomyopathy may occur in women in connection with
      pregnancy, s.c. peripartum cardiomyopathy. Other underlying causes include alcohol, drugs,
      pharmaceuticals, endocrine disorders, systemic diseases and general muscle. These factors
      account for approximately half the cases of DCM in younger and other half designated as
      idiopathic (IDCM).

      The relationship between cardiomyopathies and OSA is insufficiently studied so far. In a
      smaller population of 20 individuals with DCM, sleep apnea (OSA or CSA) had 16, ie 80% of
      patients. The first-line treatment of OSA is continues positive pressure breathing mask
      (CPAP) during sleep in patients with daytime sleepiness. Effect of CPAP therapy in patients
      with DCM and OSA is completely unknown, because many of them do not report daytime
      sleepiness. The fact that patients with heart failure and reduced pumping function usually
      have symptoms of including fatigue, it becomes difficult to distinguish what is fatigue due
      to heart failure and what is related to sleep apnea. Interpretation of the Epworth Sleepiness
      Scale (ESS) is thus difficult and possibly unsure why all patients with DCM and OSA will be
      randomized to treatment with CPAP.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Change in left ventricular ejection fraction (LVEF) six months after randomization to Continues Positive Airway Pressure (CPAP) treatment or consultation of conservative measures
time frame: 6 months
description: The primary endpoint is left ventricular ejection fraction (LVEF) measured by cardiac magnetic resonance (improvement of at least 4%) at study baseline and at 6 months after randomization to Continues Positive Airway Pressure (CPAP) or consultation of conservative measures.
measure: Change in left ventricular ejection fraction (LVEF) six months after randomization to Continues Positive Airway Pressure (CPAP) treatment or consultation of conservative measures
time frame: 6 months
description: The primary endpoint is left ventricular ejection fraction (LVEF) measured by echocardiography at study baseline and at 6 months after randomization to Continues Positive Airway Pressure (CPAP) or consultation of conservative measures.
measure: Change in measurements of diastolic function after randomization to Continues Positive Airway Pressure (CPAP) or consultation of conservative measures.
time frame: baseline and at six months
description: Secondary outcomes include measurements of diastolic function measured by cardiac magnetic resonance (CMR) and echocardiography,
measure: Change in measurements of cardiovascular biomarkers at
time frame: baseline and at six months
description: Analyzing change in cardiovascular biomarkers by analyzing blood samples
measure: Change in quality of life questioners
time frame: baseline and at six months
description: Analyzing participants response to quality of life by analyzing established questioners regarding dilated cardiomyopathy (Kansas city cardiomyopathy questionnaire KCCQ).
measure: Change in day-time sleepiness
time frame: baseline and at six month
description: Analyzing participants respons to established questioners regarding sleep apnea (Epworth sleepiness scale ESS) and
arm group label: Continues Positive Airway Pressure
arm group type: Experimental
description: Use of Continues Positive Airway Pressure (CPAP) mask every night under six months period.
arm group label: Consultation of conservative measures
arm group type: No Intervention
description: Study participants with DCM and OSA (no-CPAP), participants receive consultation of conservative measures such as avoiding alcohol before bedrest, sleeping on the side...
intervention type: Device
intervention name: Continues Positive Airway Pressure (CPAP)
description: Mask with positive airway pressure during exhalation which maintains the airway open
arm group label: Continues Positive Airway Pressure
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Maria Schaufelberger, Associate Professor
phone: +46313434085
email: maria.schaufelberger@gu.se
last name: Carmen Basic, MD
phone: +46704807426
email: carmen.basic@gu.se
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Göteborg University
investigator full name: Maria Schaufelberger
investigator title: Associate Professor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Cardiomyopathies
mesh term: Cardiomyopathy, Dilated
sharing ipd: Undecided