<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/NCT03305744</url>
  </required_header>
  <id_info>
    <org_study_id>AthletesHeartUofT</org_study_id>
    <nct_id>NCT03305744</nct_id>
  </id_info>
  <brief_title>Atrial Electromechanical Function in Endurance Athletes With and Without Atrial Fibrillation</brief_title>
  <official_title>Atrial Electromechanical Function in Middle-aged Endurance Athletes With and Without Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Toronto</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>
      This study evaluates cardiac structure and function differences between healthy endurance&#xD;
      trained athletes with atrial fibrillation and healthy age matched endurance trained athletes&#xD;
      without atrial fibrillation. It is hypothesized that despite having similar structural&#xD;
      adaptations of the heart (due to endurance training), athletes with atrial fibrillation&#xD;
      display will impaired heart functional measures compared to endurance athletes without atrial&#xD;
      fibrillation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Regular physical activity, including vigorous exercise, lowers cardiovascular risk factors,&#xD;
      including the risk of developing Atrial Fibrillation (AF), one of the most commonly diagnosed&#xD;
      types of arrhythmias. Paradoxically, despite the cardioprotective effects of exercise, middle&#xD;
      aged endurance athletes are at 5 fold risk of developing AF compared to active individuals.&#xD;
      Long standing endurance training induces significant changes to the heart- collectively known&#xD;
      as the 'athlete's heart.' While these changes may be beneficial for performance, they may be&#xD;
      conducive in promoting the risk of AF in this cohort. The aim of this study is to compare&#xD;
      cardiac structure and function in endurance athletes diagnosed with AF (n=17) and in healthy&#xD;
      aged matched endurance athletes (n=17). Male subjects between ages 45 and 65 years old with a&#xD;
      long-standing history of endurance training and competition will be recruited. Heart&#xD;
      structure and function will be compared at rest and during submaximal exercise. Participants&#xD;
      will also complete fitness assessments and questionnaires that characterize their lifetime&#xD;
      involvement in exercise training. This study will address the gap in the literature regarding&#xD;
      the interaction of endurance training and AF risk.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 30, 2018</start_date>
  <completion_date type="Anticipated">August 2021</completion_date>
  <primary_completion_date type="Anticipated">August 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Left intra-atrial electromechanical delay (ms)</measure>
    <time_frame>baseline (day 1: at first visit, one time measure)</time_frame>
    <description>Left intra-atrial electromechanical delay will be measured using cardiac echocardiography at rest and during submaximal cycling. Left intra-atrial electromechanical delay will be measured as the time interval between the initiation of the P wave (on an electrocardiogram) to the beginning of the late diastolic wave (Am wave) on echocardiography.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Left atrial reservoir function</measure>
    <time_frame>baseline (day 1: at first visit, one time measure)</time_frame>
    <description>Left atrial reservoir function will be measured by Speckle Tracking echocardiography, at 60-80 frames per second. Left atrial reservoir function will be measured by assessing left atrial reservoir strain (%), measured during ventricular systole on echocardiography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left atrial volume (mL)</measure>
    <time_frame>baseline (day 1: at first visit, one time measure)</time_frame>
    <description>Left atrial volume (mL) will be measured using echocardiography at the end of ventricular systole, prior to the opening of the mitral valve. Imaging will be acquired using two and four chamber views.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Lifetime hours of Physical Activity (# of hours)</measure>
    <time_frame>baseline (day 1: at first visit, one time measure)</time_frame>
    <description>Total lifetime hours of physical activity will be assessed using the Lifetime Physical Activity Questionnaire (LTPAQ).</description>
  </other_outcome>
  <other_outcome>
    <measure>Maximal oxygen consumption (VO2 max)</measure>
    <time_frame>baseline (day 1: at first visit, one time measure)</time_frame>
    <description>Maximal oxygen consumption (VO2 max) will be determined using a maximal treadmill test, in which a calibrated metabolic cart and indirect calorimetry will be used. VO2 max will be expressed as ml/kg/min.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">34</enrollment>
  <condition>Paroxysmal Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Endurance Athlete with Atrial Fibrillation</arm_group_label>
    <description>These are middle-aged athletes who are diagnosed with paroxysmal Atrial Fibrillation in the last 4 years, but are otherwise free of disease.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endurance Athlete without Atrial Fibrillation</arm_group_label>
    <description>These are middle-aged athletes who will serve as our control group- they have not been diagnosed with AF or any other disease.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Community sample from, but not limited to, various running, cycling, and rowing clubs for&#xD;
        middle-aged athletes. Healthy endurance athletes will be selected from an existing study&#xD;
        for convenience (non-probability sample). Endurance athletes with AF will be selected from&#xD;
        the community (probability sample).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        ALL participants:&#xD;
&#xD;
          -  endurance athlete (cyclist, runner, triathlete or other) who participate in vigorous&#xD;
             year-round training of 4-6 hours per week for a minimum of 20 years&#xD;
&#xD;
          -  participation in atleast one major competition per year (marathon/triathlon/endurance&#xD;
             competition)&#xD;
&#xD;
          -  sinus rhythm during all assessments&#xD;
&#xD;
        Inclusion criteria specific to endurance athletes with AF:&#xD;
&#xD;
          -  diagnosed with lone paroxysmal AF in the last 4 years&#xD;
&#xD;
          -  able to verify diagnosis (ECG or Holter verification/proof of diagnosis),&#xD;
&#xD;
          -  can be on any type of medication.&#xD;
&#xD;
        Inclusion criteria specific to healthy endurance athletes without AF:&#xD;
&#xD;
          -  previous participation in Athlete's Heart Study&#xD;
&#xD;
          -  has completed resting cardiac magnetic resonance imaging and resting electrocardiogram&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  females&#xD;
&#xD;
          -  no more than &gt;1 hour per week of resistance training&#xD;
&#xD;
          -  treatment or prior diagnosis of cardiovascular disease, valvular disease,&#xD;
             hypertension, heart failure, diabetes, thyroid disorder, sleep apnea, current/recent&#xD;
             viral disease, chronic inflammatory disease&#xD;
&#xD;
          -  previous (within 10 years) or current smoking&#xD;
&#xD;
          -  recreational drug use or alcohol consumption in excess of accepted standards&#xD;
&#xD;
          -  inability to provide informed consent&#xD;
&#xD;
          -  inability to verify AF diagnosis (if AF athlete).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emily Vecchiarelli, BKin</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Toronto</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jack Goodman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Toronto</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paul Dorian, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unity Health Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Goldring Center for High Performance</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5S 2C9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Molina L, Mont L, Marrugat J, Berruezo A, Brugada J, Bruguera J, Rebato C, Elosua R. Long-term endurance sport practice increases the incidence of lone atrial fibrillation in men: a follow-up study. Europace. 2008 May;10(5):618-23. doi: 10.1093/europace/eun071. Epub 2008 Apr 4.</citation>
    <PMID>18390875</PMID>
  </reference>
  <reference>
    <citation>Grimsmo J, Grundvold I, Maehlum S, Arnesen H. High prevalence of atrial fibrillation in long-term endurance cross-country skiers: echocardiographic findings and possible predictors--a 28-30 years follow-up study. Eur J Cardiovasc Prev Rehabil. 2010 Feb;17(1):100-5. doi: 10.1097/HJR.0b013e32833226be.</citation>
    <PMID>20065854</PMID>
  </reference>
  <reference>
    <citation>Calvo N, Brugada J, Sitges M, Mont L. Atrial fibrillation and atrial flutter in athletes. Br J Sports Med. 2012 Nov;46 Suppl 1:i37-43. doi: 10.1136/bjsports-2012-091171.</citation>
    <PMID>23097477</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>November 2, 2020</last_update_submitted>
  <last_update_submitted_qc>November 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Toronto</investigator_affiliation>
    <investigator_full_name>Emily Vecchiarelli</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Athlete</keyword>
  <keyword>Middle-aged</keyword>
  <keyword>Endurance training</keyword>
  <keyword>Cardiac Function</keyword>
  <keyword>Atrial Fibrillation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Participant data may be used for future study upon participant consent for their de-identified data to be used in the event that a related study is conducted. Only principal investigators will have access to records and will have the ability to share data with approved researchers.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 4, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03305744/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03305744
org study id: AthletesHeartUofT
nct id: NCT03305744
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates cardiac structure and function differences between healthy endurance
      trained athletes with atrial fibrillation and healthy age matched endurance trained athletes
      without atrial fibrillation. It is hypothesized that despite having similar structural
      adaptations of the heart (due to endurance training), athletes with atrial fibrillation
      display will impaired heart functional measures compared to endurance athletes without atrial
      fibrillation.
Regular physical activity, including vigorous exercise, lowers cardiovascular risk factors,
      including the risk of developing Atrial Fibrillation (AF), one of the most commonly diagnosed
      types of arrhythmias. Paradoxically, despite the cardioprotective effects of exercise, middle
      aged endurance athletes are at 5 fold risk of developing AF compared to active individuals.
      Long standing endurance training induces significant changes to the heart- collectively known
      as the 'athlete's heart.' While these changes may be beneficial for performance, they may be
      conducive in promoting the risk of AF in this cohort. The aim of this study is to compare
      cardiac structure and function in endurance athletes diagnosed with AF (n=17) and in healthy
      aged matched endurance athletes (n=17). Male subjects between ages 45 and 65 years old with a
      long-standing history of endurance training and competition will be recruited. Heart
      structure and function will be compared at rest and during submaximal exercise. Participants
      will also complete fitness assessments and questionnaires that characterize their lifetime
      involvement in exercise training. This study will address the gap in the literature regarding
      the interaction of endurance training and AF risk.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Left intra-atrial electromechanical delay (ms)
time frame: baseline (day 1: at first visit, one time measure)
description: Left intra-atrial electromechanical delay will be measured using cardiac echocardiography at rest and during submaximal cycling. Left intra-atrial electromechanical delay will be measured as the time interval between the initiation of the P wave (on an electrocardiogram) to the beginning of the late diastolic wave (Am wave) on echocardiography.
measure: Left atrial reservoir function
time frame: baseline (day 1: at first visit, one time measure)
description: Left atrial reservoir function will be measured by Speckle Tracking echocardiography, at 60-80 frames per second. Left atrial reservoir function will be measured by assessing left atrial reservoir strain (%), measured during ventricular systole on echocardiography.
measure: Left atrial volume (mL)
time frame: baseline (day 1: at first visit, one time measure)
description: Left atrial volume (mL) will be measured using echocardiography at the end of ventricular systole, prior to the opening of the mitral valve. Imaging will be acquired using two and four chamber views.
measure: Lifetime hours of Physical Activity (# of hours)
time frame: baseline (day 1: at first visit, one time measure)
description: Total lifetime hours of physical activity will be assessed using the Lifetime Physical Activity Questionnaire (LTPAQ).
measure: Maximal oxygen consumption (VO2 max)
time frame: baseline (day 1: at first visit, one time measure)
description: Maximal oxygen consumption (VO2 max) will be determined using a maximal treadmill test, in which a calibrated metabolic cart and indirect calorimetry will be used. VO2 max will be expressed as ml/kg/min.
arm group label: Endurance Athlete with Atrial Fibrillation
description: These are middle-aged athletes who are diagnosed with paroxysmal Atrial Fibrillation in the last 4 years, but are otherwise free of disease.
arm group label: Endurance Athlete without Atrial Fibrillation
description: These are middle-aged athletes who will serve as our control group- they have not been diagnosed with AF or any other disease.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Emily Vecchiarelli, BKin
role: Principal Investigator
affiliation: University of Toronto
last name: Jack Goodman, PhD
role: Principal Investigator
affiliation: University of Toronto
last name: Paul Dorian, MD
role: Principal Investigator
affiliation: Unity Health Toronto
facility: 
country: Canada
citation: Molina L, Mont L, Marrugat J, Berruezo A, Brugada J, Bruguera J, Rebato C, Elosua R. Long-term endurance sport practice increases the incidence of lone atrial fibrillation in men: a follow-up study. Europace. 2008 May;10(5):618-23. doi: 10.1093/europace/eun071. Epub 2008 Apr 4.
PMID: 18390875
citation: Grimsmo J, Grundvold I, Maehlum S, Arnesen H. High prevalence of atrial fibrillation in long-term endurance cross-country skiers: echocardiographic findings and possible predictors--a 28-30 years follow-up study. Eur J Cardiovasc Prev Rehabil. 2010 Feb;17(1):100-5. doi: 10.1097/HJR.0b013e32833226be.
PMID: 20065854
citation: Calvo N, Brugada J, Sitges M, Mont L. Atrial fibrillation and atrial flutter in athletes. Br J Sports Med. 2012 Nov;46 Suppl 1:i37-43. doi: 10.1136/bjsports-2012-091171.
PMID: 23097477
responsible party type: Principal Investigator
investigator affiliation: University of Toronto
investigator full name: Emily Vecchiarelli
investigator title: Principal Investigator
mesh term: Atrial Fibrillation
sharing ipd: Undecided
ipd description: Participant data may be used for future study upon participant consent for their de-identified data to be used in the event that a related study is conducted. Only principal investigators will have access to records and will have the ability to share data with approved researchers.
provided document: 