<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/NCT03227393</url>
  </required_header>
  <id_info>
    <org_study_id>2015-7643</org_study_id>
    <nct_id>NCT03227393</nct_id>
  </id_info>
  <brief_title>The Effect of Yoga on Cardiac Sympathetic Innervation Evaluated by I-123 mIBG</brief_title>
  <official_title>The Effect of Yoga on Cardiac Sympathetic Innervation Evaluated by I-123 mIBG</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Cincinnati</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 purpose of this study is to evaluate if yoga practice will reduce cardiac sympathetic&#xD;
      activity and subsequently cardiac arrhythmias.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects with reduced ejection fraction will be randomized to 8 weeks Yoga training (1 in&#xD;
      class session and home practice) vs. no Yoga. They will undergo holter monitoring, cardiac&#xD;
      device interrogation, and I-123 mIBG imaging at the beginning and end of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study was not opened at site.&#xD;
  </why_stopped>
  <start_date type="Actual">September 30, 2017</start_date>
  <completion_date type="Actual">October 27, 2017</completion_date>
  <primary_completion_date type="Actual">October 27, 2017</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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiac sympathetic activity following yoga training</measure>
    <time_frame>8 weeks</time_frame>
    <description>A comparison of of the I-123 MIBG heart to mediastinal uptake ratio at baseline and completion of the yoga training.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relationship between I-123MIBG heart-to-mediastinal ratios and the total atrial and ventricular arrhythmia burden.</measure>
    <time_frame>8 weeks</time_frame>
    <description>Association between heart to mediastinum ration and ventricular arrhythmia burden</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Heart Failure, Systolic</condition>
  <arm_group>
    <arm_group_label>No yoga training</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This will be the control arm. The patients in this arm will not receive any yoga training. They will be continued on all their home, guideline-directed heart failure medications. They will undergo the same baseline and study completion evaluation as the treatment arm, including an I-123 MIBG scan, 24-hour holter monitoring and device interrogation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Yoga training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients in this arm will receive yoga training. This includes weekly group yoga sessions consisting of breathing exercises, yoga poses, and relaxation and meditation lasting for about 80-90 minutes total. Patients will be asked to do home yoga practices at least twice a week and to document the date and time. Patients in this arm will have the same baseline and study completion evaluation as the control arm, including an I-123 MIBG scan, 24-hour holter monitoring and device interrogation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Yoga training</intervention_name>
    <description>Subjects will complete in class yoga training weekly for 8 weeks with additional practice at home</description>
    <arm_group_label>Yoga training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Negative pregnancy test in females&#xD;
&#xD;
          -  Ejection Fraction &lt;/= 40% assessed by echocardiogram within the last 12 months&#xD;
&#xD;
          -  Stable dose of heart failure medications including afterload reducing medication such&#xD;
             as ACE-I, ARB and hydralazine; beta blockers; digoxin and aldosterone antagonist for&#xD;
             at least 4 months and no anticipated changes for 8 weeks. (i.e. no greater than a 50%&#xD;
             dose change within the past month)&#xD;
&#xD;
          -  Has an implantable pacemaker or ICD&#xD;
&#xD;
          -  NYHA II-IV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant or lactating female&#xD;
&#xD;
          -  females without a pregnancy test&#xD;
&#xD;
          -  co-administration of a positive inotrope (i.e. milrinone or dobutamine)&#xD;
&#xD;
          -  history of significant medical non-compliance&#xD;
&#xD;
          -  unwilling to adhere to the protocol&#xD;
&#xD;
          -  Orthopedic limitation making yoga participation difficult&#xD;
&#xD;
          -  Underlying cardiac rhythm other than sinus rhythm&#xD;
&#xD;
          -  Recent history within 6 months prior to enrollment of unstable coronary artery disease&#xD;
             (unstable angina, recent heart attack, recent revascularization, or decompensated&#xD;
             heart failure)&#xD;
&#xD;
          -  implantation of a cardiac resynchronization therapy device in the past 3 months.&#xD;
&#xD;
          -  TIA, CVA, or major surgery in the past 3 months&#xD;
&#xD;
          -  iodine or adreview (123-MIBG) allergy&#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>Mehran Attari</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Cincinnati Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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    <citation>Heidenreich PA, Trogdon JG, Khavjou OA, Butler J, Dracup K, Ezekowitz MD, Finkelstein EA, Hong Y, Johnston SC, Khera A, Lloyd-Jones DM, Nelson SA, Nichol G, Orenstein D, Wilson PW, Woo YJ; American Heart Association Advocacy Coordinating Committee; Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Arteriosclerosis; Thrombosis and Vascular Biology; Council on Cardiopulmonary; Critical Care; Perioperative and Resuscitation; Council on Cardiovascular Nursing; Council on the Kidney in Cardiovascular Disease; Council on Cardiovascular Surgery and Anesthesia, and Interdisciplinary Council on Quality of Care and Outcomes Research. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation. 2011 Mar 1;123(8):933-44. doi: 10.1161/CIR.0b013e31820a55f5. Epub 2011 Jan 24.</citation>
    <PMID>21262990</PMID>
  </results_reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>March 18, 2018</last_update_submitted>
  <last_update_submitted_qc>March 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cincinnati</investigator_affiliation>
    <investigator_full_name>Mehran Attari</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Heart Failure, Systolic</keyword>
  <keyword>Defibrillators, Implantable</keyword>
  <keyword>Pacemaker, Artificial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Heart Failure, Systolic</mesh_term>
    <mesh_term>Systolic Murmurs</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/NCT03227393
org study id: 2015-7643
nct id: NCT03227393
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate if yoga practice will reduce cardiac sympathetic
      activity and subsequently cardiac arrhythmias.
Subjects with reduced ejection fraction will be randomized to 8 weeks Yoga training (1 in
      class session and home practice) vs. no Yoga. They will undergo holter monitoring, cardiac
      device interrogation, and I-123 mIBG imaging at the beginning and end of the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
measure: Cardiac sympathetic activity following yoga training
time frame: 8 weeks
description: A comparison of of the I-123 MIBG heart to mediastinal uptake ratio at baseline and completion of the yoga training.
measure: Relationship between I-123MIBG heart-to-mediastinal ratios and the total atrial and ventricular arrhythmia burden.
time frame: 8 weeks
description: Association between heart to mediastinum ration and ventricular arrhythmia burden
arm group label: No yoga training
arm group type: No Intervention
description: This will be the control arm. The patients in this arm will not receive any yoga training. They will be continued on all their home, guideline-directed heart failure medications. They will undergo the same baseline and study completion evaluation as the treatment arm, including an I-123 MIBG scan, 24-hour holter monitoring and device interrogation.
arm group label: Yoga training
arm group type: Experimental
description: The patients in this arm will receive yoga training. This includes weekly group yoga sessions consisting of breathing exercises, yoga poses, and relaxation and meditation lasting for about 80-90 minutes total. Patients will be asked to do home yoga practices at least twice a week and to document the date and time. Patients in this arm will have the same baseline and study completion evaluation as the control arm, including an I-123 MIBG scan, 24-hour holter monitoring and device interrogation.
intervention type: Behavioral
intervention name: Yoga training
description: Subjects will complete in class yoga training weekly for 8 weeks with additional practice at home
arm group label: Yoga training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mehran Attari
role: Principal Investigator
affiliation: University of Cincinnati
facility: 
country: United States
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PMID: 21262990
responsible party type: Principal Investigator
investigator affiliation: University of Cincinnati
investigator full name: Mehran Attari
investigator title: Professor of Medicine
mesh term: Heart Failure
mesh term: Heart Failure, Systolic
mesh term: Systolic Murmurs
sharing ipd: No