<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/NCT03025737</url>
  </required_header>
  <id_info>
    <org_study_id>Semmelweis Sport</org_study_id>
    <nct_id>NCT03025737</nct_id>
  </id_info>
  <brief_title>Semmelweis Sport Study</brief_title>
  <official_title>Semmelweis Sport - Complex Cardiovascular Screening of Elite, Recreational, Young and Master Athletes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Semmelweis University Heart and Vascular Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Research, Development and Innovation Office (NKFIH) of Hungary (K 120277).</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Semmelweis University Heart and Vascular Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present proposal is to investigate the development of distinct morphological,&#xD;
      functional, biochemical and molecular aspects of short- and long-term sport-induced changes&#xD;
      in the heart, to get a better understanding on the (patho)physiology of athlete's heart. The&#xD;
      main goal of our research is to deepen our knowledge on the proper differentiation between&#xD;
      beneficial (physiological) and harmful (pathological) consequences of professional sport,&#xD;
      thereby effectively preventing potential cardiovascular complications of athletes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CLINICAL METHODS&#xD;
&#xD;
        1. Sport specific questionnaire, patient history and physical examinations - In our&#xD;
           detailed questionnaire, specific information is collected about quantity and quality of&#xD;
           training, personal and family history and presence of sport specific and general&#xD;
           symptoms.&#xD;
&#xD;
        2. Laboratory biochemical examination - Besides the regular routine laboratory parameters,&#xD;
           several specific parameters associated with physical exercise are planned to be&#xD;
           measured, such as cardiac biomarkers.&#xD;
&#xD;
        3. 12-lead ECG - Resting standard 12-lead digital ECG will be recorded. Extended analysis&#xD;
           will be performed according to the latest recommendations.&#xD;
&#xD;
        4. Holter ECG - 24 hour Holter ECG will be recorded. Extended Holter ECG analysis will be&#xD;
           performed.&#xD;
&#xD;
        5. Detailed echocardiography&#xD;
&#xD;
        6. Detailed CMR examination&#xD;
&#xD;
        7. Body composition analysis - With a sophisticated bio-electrical impedance analysis,&#xD;
           comprehensive whole body composition and hydration analysis will be performed.&#xD;
&#xD;
        8. Cardiopulmonary exercise testing - Sport specific protocols will be used on both&#xD;
           treadmill and bike ergometers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">January 2020</completion_date>
  <primary_completion_date type="Anticipated">January 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>The primary analysis will be an investigation regarding the athletic adaptation using CMR</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The primary analysis will be an investigation regarding the athletic adaptation using cardiopulmonary exercise testing</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The primary analysis will be an investigation regarding the athletic adaptation using resting ECG</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The primary analysis will be an investigation regarding the athletic adaptation using 24-Hour Holter ECG</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Athletes Heart</condition>
  <arm_group>
    <arm_group_label>athletes</arm_group_label>
    <description>Healthy highly trained elite athletes, recreational athletes, young and master athletes free of known structural myocardial disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>controls</arm_group_label>
    <description>Healthy volunteers without a history of competitive physical exercise</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Samples with DNA, serum, plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Elite, recreational, young and master athletes Healthy volunteers without a history of&#xD;
        competitive physical exercise&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age&#xD;
&#xD;
          -  no known cardiovascular disease&#xD;
&#xD;
          -  history of sport activity (athletes)&#xD;
&#xD;
          -  no history of competitive sport (controls)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of known relevant cardiac disease (including cardiomyopathies)&#xD;
&#xD;
          -  Contraindication to MRI or cardiopulmonary exercise testing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hajnalka Vágó, MD, PhD</last_name>
    <phone>+36208258058</phone>
    <email>vagoha@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Orsolya Kiss, MD, PhD</last_name>
    <phone>+36208258029</phone>
    <email>dr.orsolya.kiss@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Heart and Vascular Center, Semmelweis University</name>
      <address>
        <city>Budapest</city>
        <zip>1122</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lilla Halász</last_name>
      <phone>+36206632509</phone>
      <email>merkely.study@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>January 18, 2017</last_update_submitted>
  <last_update_submitted_qc>January 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Semmelweis University Heart and Vascular Center</investigator_affiliation>
    <investigator_full_name>Bela Merkely</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Hypertrophy, Left Ventricular</keyword>
  <keyword>Ventricular Remodeling</keyword>
  <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/NCT03025737
org study id: Semmelweis Sport
nct id: NCT03025737
lead sponsor: 
collaborator: 
has dmc: No
The aim of the present proposal is to investigate the development of distinct morphological,
      functional, biochemical and molecular aspects of short- and long-term sport-induced changes
      in the heart, to get a better understanding on the (patho)physiology of athlete's heart. The
      main goal of our research is to deepen our knowledge on the proper differentiation between
      beneficial (physiological) and harmful (pathological) consequences of professional sport,
      thereby effectively preventing potential cardiovascular complications of athletes.
CLINICAL METHODS

        1. Sport specific questionnaire, patient history and physical examinations - In our
           detailed questionnaire, specific information is collected about quantity and quality of
           training, personal and family history and presence of sport specific and general
           symptoms.

        2. Laboratory biochemical examination - Besides the regular routine laboratory parameters,
           several specific parameters associated with physical exercise are planned to be
           measured, such as cardiac biomarkers.

        3. 12-lead ECG - Resting standard 12-lead digital ECG will be recorded. Extended analysis
           will be performed according to the latest recommendations.

        4. Holter ECG - 24 hour Holter ECG will be recorded. Extended Holter ECG analysis will be
           performed.

        5. Detailed echocardiography

        6. Detailed CMR examination

        7. Body composition analysis - With a sophisticated bio-electrical impedance analysis,
           comprehensive whole body composition and hydration analysis will be performed.

        8. Cardiopulmonary exercise testing - Sport specific protocols will be used on both
           treadmill and bike ergometers.
observational model: Case-Control
time perspective: Prospective
measure: The primary analysis will be an investigation regarding the athletic adaptation using CMR
time frame: Baseline
measure: The primary analysis will be an investigation regarding the athletic adaptation using cardiopulmonary exercise testing
time frame: Baseline
measure: The primary analysis will be an investigation regarding the athletic adaptation using resting ECG
time frame: Baseline
measure: The primary analysis will be an investigation regarding the athletic adaptation using 24-Hour Holter ECG
time frame: Baseline
arm group label: athletes
description: Healthy highly trained elite athletes, recreational athletes, young and master athletes free of known structural myocardial disease
arm group label: controls
description: Healthy volunteers without a history of competitive physical exercise
Samples with DNA, serum, plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Hajnalka Vágó, MD, PhD
phone: +36208258058
email: vagoha@gmail.com
last name: Orsolya Kiss, MD, PhD
phone: +36208258029
email: dr.orsolya.kiss@gmail.com
facility: 
status: Recruiting
contact: 
country: Hungary
responsible party type: Principal Investigator
investigator affiliation: Semmelweis University Heart and Vascular Center
investigator full name: Bela Merkely
investigator title: Principal Investigator
sharing ipd: No