xml: <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/NCT06039397</url>
    </required_header>
    <id_info>
      <org_study_id>01.202303.046</org_study_id>
      <nct_id>NCT06039397</nct_id>
    </id_info>
    <brief_title>The Effect of Semi Fowler 30' Right Lateral on Cardiac Output in Acute Heart Failure</brief_title>
    <acronym>SETTLECO</acronym>
    <official_title>The Effect of Semi Fowler 30' Right Lateral on Cardiac Output in Acute Heart Failure</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ryan Budiyanto</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Cardiovascular Center Harapan Kita Hospital Indonesia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Indonesia University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Heart failure is a special clinical syndrome such as difficulty breathing, fatigue, and&#xD;
        swollen legs characterized by increased JVP, crackle lung sounds, and peripheral edema caused&#xD;
        by heart disorders both structural and/or functional, resulting in decreased cardiac output&#xD;
        and increased intracardiac pressure at rest and activity. Body positioning has been shown to&#xD;
        affect stroke volume and parasympathetic modulating activity. The right lateral 30&quot;&#xD;
        semifowler position is a very safe position in heart failure patients admitted to the ICU.&#xD;
        Although body positioning can affect stroke volume, and parasympathetic modulation, it is not&#xD;
        yet clear what effect it has on cardiac output&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cardiac Output</measure>
      <time_frame>15 Minutes</time_frame>
      <description>The amount of blood volume pumped by the heart for 1 minute in liters</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Cardiac Output, High</condition>
    <condition>Heart Failure</condition>
    <condition>Pulmonary Edema With Heart Failure</condition>
    <condition>Dyspnea; Cardiac</condition>
    <condition>Arrythmia</condition>
    <arm_group>
      <arm_group_label>LVEF &lt;50%</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>LVEF&gt;30%</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Semifowler 30&quot; Right Lateral Body Position</intervention_name>
      <description>Semifowler 30' Right Lateral Body Position Is a regulation of body position by placing the patient's body in a semi-fowler and lateral resting position of 30 degrees</description>
      <arm_group_label>LVEF &lt;50%</arm_group_label>
      <arm_group_label>LVEF&gt;30%</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The patient was diagnosed with acute decompensated heart failure, fully conscious, not&#xD;
               intubated, &gt;18 years old, had no mobility problems, palpable radial artery pulsation,&#xD;
               was not under the influence of anti-hypotensive drugs, was willing to be a respondent,&#xD;
               LVEF &lt;50%.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pulmonary edema, severe valve disease comorbidities, and receiving high doses of&#xD;
               anti-hypotensive treatment, heart failure remission in the last 3 months, finger&#xD;
               edema, use of mechanical circulatory aids, irregular rhythms, artificial pacemaker&#xD;
               attached, peripheral perfusion disorders.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Ryan Budiyanto</name>
        <address>
          <city>Jakarta</city>
          <state>West Jakarta</state>
          <zip>11420</zip>
          <country>Indonesia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ryan Budiyanto</last_name>
        <phone>+62215684093</phone>
        <phone_ext>1262</phone_ext>
        <email>ryanbudiyanto.ui@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>National Cardiovascular Center Harapan Kita</last_name>
        <phone_ext>1262</phone_ext>
        <email>ryanbudiyanto.ui@gmail.com</email>
      </contact_backup>
      <investigator>
        <last_name>Ryan Budiyanto</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Indonesia</country>
    </location_countries>
    <link>
      <url>https://www.lontar.ui.ac.id/detail?id=20390020&amp;lokasi=lokal</url>
      <description>Effect of right lateral position on hemodynamics and comfort of patients with heart failure at Harapan Kita</description>
    </link>
    <reference>
      <citation>Gottlieb LA, Blanco LSY, Hocini M, Dekker LRC, Coronel R. Self-Reported Onset of Paroxysmal Atrial Fibrillation Is Related to Sleeping Body Position. Front Physiol. 2021 Jul 15;12:708650. doi: 10.3389/fphys.2021.708650. eCollection 2021.</citation>
      <PMID>34335312</PMID>
    </reference>
    <reference>
      <citation>Carlisle MA, Fudim M, DeVore AD, Piccini JP. Heart Failure and Atrial Fibrillation, Like Fire and Fury. JACC Heart Fail. 2019 Jun;7(6):447-456. doi: 10.1016/j.jchf.2019.03.005.</citation>
      <PMID>31146871</PMID>
    </reference>
    <reference>
      <citation>Chen GY, Kuo CD. The effect of the lateral decubitus position on vagal tone. Anaesthesia. 1997 Jul;52(7):653-7. doi: 10.1111/j.1365-2044.1997.114-az0106.x.</citation>
      <PMID>9244024</PMID>
    </reference>
    <results_reference>
      <citation>Miyamoto S, Fujita M, Sekiguchi H, Okano Y, Nagaya N, Ueda K, Tamaki S, Nohara R, Eiho S, Sasayama S. Effects of posture on cardiac autonomic nervous activity in patients with congestive heart failure. J Am Coll Cardiol. 2001 Jun 1;37(7):1788-93. doi: 10.1016/s0735-1097(01)01249-9.</citation>
      <PMID>11401112</PMID>
    </results_reference>
    <results_reference>
      <citation>Pan H, Xu Z, Yan H, Gao Y, Chen Z, Song J, Zhang Y. Lying position classification based on ECG waveform and random forest during sleep in healthy people. Biomed Eng Online. 2018 Aug 30;17(1):116. doi: 10.1186/s12938-018-0548-7.</citation>
      <PMID>30165874</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Indonesia University</investigator_affiliation>
      <investigator_full_name>Ryan Budiyanto</investigator_full_name>
      <investigator_title>S.Kep,Ners</investigator_title>
    </responsible_party>
    <keyword>Cardiac Output</keyword>
    <keyword>Heart Failure</keyword>
    <keyword>Body Positioning</keyword>
    <keyword>Right Lateral Body Position</keyword>
    <keyword>Semifowler</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dyspnea</mesh_term>
      <mesh_term>Pulmonary Edema</mesh_term>
      <mesh_term>Heart Failure</mesh_term>
      <mesh_term>Cardiac Output, High</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06039397
  org study id: 01.202303.046
  nct id: NCT06039397
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Heart failure is a special clinical syndrome such as difficulty breathing, fatigue, and
        swollen legs characterized by increased JVP, crackle lung sounds, and peripheral edema caused
        by heart disorders both structural and/or functional, resulting in decreased cardiac output
        and increased intracardiac pressure at rest and activity. Body positioning has been shown to
        affect stroke volume and parasympathetic modulating activity. The right lateral 30"
        semifowler position is a very safe position in heart failure patients admitted to the ICU.
        Although body positioning can affect stroke volume, and parasympathetic modulation, it is not
        yet clear what effect it has on cardiac output
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Supportive Care
  masking: Single (Investigator)
  measure: Cardiac Output
  time frame: 15 Minutes
  description: The amount of blood volume pumped by the heart for 1 minute in liters
  arm group label: LVEF <50%
  arm group type: Active Comparator
  arm group label: LVEF>30%
  arm group type: Active Comparator
  intervention type: Behavioral
  intervention name: Semifowler 30" Right Lateral Body Position
  description: Semifowler 30' Right Lateral Body Position Is a regulation of body position by placing the patient's body in a semi-fowler and lateral resting position of 30 degrees
  arm group label: LVEF <50%
  arm group label: LVEF>30%
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Indonesia
  url: https://www.lontar.ui.ac.id/detail?id=20390020&lokasi=lokal
  description: Effect of right lateral position on hemodynamics and comfort of patients with heart failure at Harapan Kita
  citation: Gottlieb LA, Blanco LSY, Hocini M, Dekker LRC, Coronel R. Self-Reported Onset of Paroxysmal Atrial Fibrillation Is Related to Sleeping Body Position. Front Physiol. 2021 Jul 15;12:708650. doi: 10.3389/fphys.2021.708650. eCollection 2021.
  PMID: 34335312
  citation: Carlisle MA, Fudim M, DeVore AD, Piccini JP. Heart Failure and Atrial Fibrillation, Like Fire and Fury. JACC Heart Fail. 2019 Jun;7(6):447-456. doi: 10.1016/j.jchf.2019.03.005.
  PMID: 31146871
  citation: Chen GY, Kuo CD. The effect of the lateral decubitus position on vagal tone. Anaesthesia. 1997 Jul;52(7):653-7. doi: 10.1111/j.1365-2044.1997.114-az0106.x.
  PMID: 9244024
  citation: Miyamoto S, Fujita M, Sekiguchi H, Okano Y, Nagaya N, Ueda K, Tamaki S, Nohara R, Eiho S, Sasayama S. Effects of posture on cardiac autonomic nervous activity in patients with congestive heart failure. J Am Coll Cardiol. 2001 Jun 1;37(7):1788-93. doi: 10.1016/s0735-1097(01)01249-9.
  PMID: 11401112
  citation: Pan H, Xu Z, Yan H, Gao Y, Chen Z, Song J, Zhang Y. Lying position classification based on ECG waveform and random forest during sleep in healthy people. Biomed Eng Online. 2018 Aug 30;17(1):116. doi: 10.1186/s12938-018-0548-7.
  PMID: 30165874
  responsible party type: Sponsor-Investigator
  investigator affiliation: Indonesia University
  investigator full name: Ryan Budiyanto
  investigator title: S.Kep,Ners
  mesh term: Dyspnea
  mesh term: Pulmonary Edema
  mesh term: Heart Failure
  mesh term: Cardiac Output, High