<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/NCT03804827</url>
  </required_header>
  <id_info>
    <org_study_id>181121</org_study_id>
    <nct_id>NCT03804827</nct_id>
  </id_info>
  <brief_title>Sleep Disordered Breathing in Acute Congestive Heart Failure</brief_title>
  <official_title>Impact of Sleep Disordered Breathing on Cardiac Injury in Acutely Decompensated Congestive Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Diego</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>
      The goal of this study is to determine if sleep disordered breathing results in a measurable&#xD;
      degree of overnight myocardial stress/injury in patients with acutely decompensated&#xD;
      congestive heart failure. A secondary goal is to determine of a period of medical management&#xD;
      attenuates this sleep disordered breathing-induced cardiac injury in this patient population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Consecutive patients admitted to the hospital with acutely decompensated heart failure will&#xD;
      be identified for potential enrollment in this study. Enrolled patients will first be asked&#xD;
      to complete questionnaires to assess their symptoms and risk of having sleep apnea.&#xD;
&#xD;
      Relevant information will be obtained from the electronic medical record (age, gender, body&#xD;
      mass index, co-morbidities, medications, prior echocardiography results). Subjects will then&#xD;
      undergo a &quot;type III&quot; portable monitoring sleep study on the first or second night of their&#xD;
      hospital admission, which measures respiratory effort, nasal airflow, oxyhemoglobin&#xD;
      saturation, and heart rate. Blood samples will be collected on the evening before (08:00 PM&#xD;
      +/- 2 hours), and the morning after (06:00 AM +/-2 hours) sleep apnea testing. If not&#xD;
      otherwise obtained clinically, echocardiography will be obtained within 48 hours of&#xD;
      admission. After a period of medical management for acutely decompensated heart failure,&#xD;
      subjects will then have a second portable sleep apnea study (with associated pre and&#xD;
      post-sleep blood draws) on the evening prior to discharge (approximately hospital day 5 or&#xD;
      6). Later, clinical outcomes such as incidence of renal dysfunction, hospital length of stay&#xD;
      etc. will be collected from the electronic medical record. Blood samples will be processed,&#xD;
      stored, and subsequently analyzed for high-sensitivity cardiac troponin T and I.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Actual">August 3, 2021</completion_date>
  <primary_completion_date type="Actual">August 3, 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overnight Troponin Change Admission</measure>
    <time_frame>10 hours</time_frame>
    <description>Overnight change in serum troponin concentration PRE vs POST sleep</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overnight Troponin Change Discharge</measure>
    <time_frame>10 hours</time_frame>
    <description>Overnight change in serum troponin concentration PRE vs POST sleep</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">19</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <condition>Heart Failure; With Decompensation</condition>
  <arm_group>
    <arm_group_label>Heart Failure With Sleep Disordered Breathing</arm_group_label>
    <description>AHI3% &gt;/= 5 events per hour of sleep.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Heart Failure without Sleep Disordered Breathing</arm_group_label>
    <description>AHI3% &lt; 5 events per hour of sleep.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum retention&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients admitted to University of California San Diego Sulpizio Cardiovascular&#xD;
        Center, Jacobs Medical Center, and Thornton Hospital with acutely decompensated heart&#xD;
        failure will be identified in the emergency department, or upon admission to the cardiology&#xD;
        or hospitalist (general medical) service.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients age 18-80 years admitted to University of California San Diego La Jolla&#xD;
             campus (Sulpizio Cardiovascular Center, Jacobs Medical Center, and Thornton Hospital)&#xD;
             with acute decompensated heart failure will be identified in the emergency department,&#xD;
             or upon admission to the cardiology or inpatient general medical services.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known diagnosis of sleep disordered breathing and on treatment while hospitalized.&#xD;
&#xD;
          -  Suspected acute coronary syndrome as determined by the primary clinical team.&#xD;
&#xD;
          -  Intensive care unit level care.&#xD;
&#xD;
          -  Requiring advanced heart failure therapy such as inotrope infusion, mechanical&#xD;
             circulatory support etc.&#xD;
&#xD;
          -  Intolerance of study procedures.&#xD;
&#xD;
          -  Clinical attending physician refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Altman Clinical and Translational Research Institute</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92093-0990</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>August 3, 2021</last_update_submitted>
  <last_update_submitted_qc>August 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Robert L. Owens</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Sleep</keyword>
  <keyword>OSA</keyword>
  <keyword>CSA</keyword>
  <keyword>CHF</keyword>
  <keyword>Heart Failure</keyword>
  <keyword>Troponin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</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/NCT03804827
org study id: 181121
nct id: NCT03804827
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this study is to determine if sleep disordered breathing results in a measurable
      degree of overnight myocardial stress/injury in patients with acutely decompensated
      congestive heart failure. A secondary goal is to determine of a period of medical management
      attenuates this sleep disordered breathing-induced cardiac injury in this patient population.
Consecutive patients admitted to the hospital with acutely decompensated heart failure will
      be identified for potential enrollment in this study. Enrolled patients will first be asked
      to complete questionnaires to assess their symptoms and risk of having sleep apnea.

      Relevant information will be obtained from the electronic medical record (age, gender, body
      mass index, co-morbidities, medications, prior echocardiography results). Subjects will then
      undergo a "type III" portable monitoring sleep study on the first or second night of their
      hospital admission, which measures respiratory effort, nasal airflow, oxyhemoglobin
      saturation, and heart rate. Blood samples will be collected on the evening before (08:00 PM
      +/- 2 hours), and the morning after (06:00 AM +/-2 hours) sleep apnea testing. If not
      otherwise obtained clinically, echocardiography will be obtained within 48 hours of
      admission. After a period of medical management for acutely decompensated heart failure,
      subjects will then have a second portable sleep apnea study (with associated pre and
      post-sleep blood draws) on the evening prior to discharge (approximately hospital day 5 or
      6). Later, clinical outcomes such as incidence of renal dysfunction, hospital length of stay
      etc. will be collected from the electronic medical record. Blood samples will be processed,
      stored, and subsequently analyzed for high-sensitivity cardiac troponin T and I.
observational model: Cohort
time perspective: Prospective
measure: Overnight Troponin Change Admission
time frame: 10 hours
description: Overnight change in serum troponin concentration PRE vs POST sleep
measure: Overnight Troponin Change Discharge
time frame: 10 hours
description: Overnight change in serum troponin concentration PRE vs POST sleep
arm group label: Heart Failure With Sleep Disordered Breathing
description: AHI3% >/= 5 events per hour of sleep.
arm group label: Heart Failure without Sleep Disordered Breathing
description: AHI3% < 5 events per hour of sleep.
Serum retention
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Robert L. Owens
investigator title: Assistant Professor
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Heart Failure
sharing ipd: No