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/NCT06040242</url>
    </required_header>
    <id_info>
      <org_study_id>EAP_2020</org_study_id>
      <nct_id>NCT06040242</nct_id>
    </id_info>
    <brief_title>Arrhythmogenic Activity During Exercise in ARVC Patients</brief_title>
    <official_title>Characterization of Arrhythmogenic Activity During and After Physical Exercise in Patients With Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Swiss Federal Institute of Technology</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Zurich</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Swiss Federal Institute of Technology</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>
        Current guidelines advocate that ARVC patients, typically young and active individuals with a&#xD;
        significant history of competitive endurance sports, cease endurance training in favour of&#xD;
        activities with low cardiac burden such as bowling and golf. Empirically, it is often&#xD;
        suggested that heart rate during exercise should not exceed 100-120 bpm in these patients,&#xD;
        but these guidelines are arbitrary and not scientifically based. In practice, it is estimated&#xD;
        that up to 50% of patients do not comply with these recommendations .&#xD;
  &#xD;
        Adequate quantification of the arrhythmogenic burden, defined as premature ventricular beats&#xD;
        in proportion to all heart beats in each period of time, and cardiac load (defined as stroke&#xD;
        volume for volume load and systolic blood pressure for pressure load) experienced by ARVC&#xD;
        patients when performing different types of physical exercise would be a first step towards&#xD;
        designing a safe and effective intervention so that these patients can profit from an active&#xD;
        life style.&#xD;
  &#xD;
        This study therefore aims to quantify and describe the arrhythmogenic burden and cardiac load&#xD;
        experienced by patients with ARVC while performing different physical exercise over a range&#xD;
        of intensities - all strictly within the range currently recommended by different&#xD;
        cardiological societies.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study, ARVC patients with different genotypes will perform a series of different&#xD;
        physical activities, including treadmill walking, cycling at different intensities, biceps&#xD;
        curls and loaded squats while undergoing extensive cardiovascular monitoring.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>count of premature ventricular beats during and after the activities</measure>
      <time_frame>measured during the 3 min of activity and the 10 min of recovery</time_frame>
      <description>as above</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>cardiac load during different activities, as rate-pressure product</measure>
      <time_frame>measured during the 3 min of activity</time_frame>
      <description>product of heart rate and systolic blood pressure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>cardiac load during different activities, as cardiac output</measure>
      <time_frame>measured during the 3 min of activity</time_frame>
      <description>product of heart rate and stroke volume, in L/min</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>cardiac load during different activities, as peak blood pressure</measure>
      <time_frame>measured during the 3 min of activity</time_frame>
      <description>systolic blood pressure, in mmHg</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">64</enrollment>
    <condition>Arrhythmogenic Right Ventricular Cardiomyopathy</condition>
    <arm_group>
      <arm_group_label>Patients Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All patients will perform all exercises. Arrhythmogenic activity will compared with that assessed during treadmill walking.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Exercise</intervention_name>
      <description>Participants will perform 3 min of the different activities, followed by a 10-min recovery window.</description>
      <arm_group_label>Patients Group</arm_group_label>
      <other_name>cycling, squats, biceps curls, walking</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Definitive ARVC diagnosis according to the modified 2010 ARVC Task Force Criteria&#xD;
  &#xD;
            -  Pathogenic / likely pathogenic variant in one of the following desmosomal genes:&#xD;
               plakophilin-2 (PKP-2), desmoglein-2 (DSG-2) or desmoplakin (DSP) or gene-elusive&#xD;
               definite ARVC (i.e., genetic test performed but no pathogenic / likely pathogenic&#xD;
               variant found)&#xD;
  &#xD;
            -  Agreement with responsible primary cardiologist that study participation is not&#xD;
               considered beyond acceptable levels of physical activity for this particular patient&#xD;
  &#xD;
            -  No history of exercise-induced syncope in the 6 months prior to study participation&#xD;
  &#xD;
            -  No history of sudden cardiac arrest in the 6 months prior to study participation&#xD;
  &#xD;
            -  In patients who suffered from sudden cardiac arrest/arrhythmic syncope, only those&#xD;
               having an implantable cardioverter-defibrillator (ICD) and being under&#xD;
               beta-blockers/antiarrhythmic drugs are eligible for study inclusion&#xD;
  &#xD;
            -  Informed Consent as documented by signature (Appendix Informed Consent Form)&#xD;
  &#xD;
            -  Age: &gt; 18 years&#xD;
  &#xD;
            -  Body-Mass-Index (BMI): 18.5 - 29.9 kg･m-2&#xD;
  &#xD;
            -  Willing to adhere to the following study rules:&#xD;
  &#xD;
                 -  No intense exercise 48h prior to testing&#xD;
  &#xD;
                 -  No exercise 24h prior to testing&#xD;
  &#xD;
                 -  Sleep at least 7h the two nights before testing On test day&#xD;
  &#xD;
                 -  No caffeinated food or drink before testing on test day&#xD;
  &#xD;
                 -  No alcohol before testing on test day&#xD;
  &#xD;
                 -  Fully compliant with normal medication regimen including beta-blockers and&#xD;
                    antiarrhythmic medication&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  No genetic test history for ARVC variants&#xD;
  &#xD;
            -  Heart failure with severely reduced left ventricular ejection fraction (LVEF &lt;35%)&#xD;
  &#xD;
            -  For women: Pregnancy, breastfeeding, or intention to become pregnant during the study.&#xD;
  &#xD;
            -  Known or suspected non-compliance, drug, or alcohol abuse&#xD;
  &#xD;
            -  Inability to follow the procedures of the study, e.g., due to language problems,&#xD;
               psychological disorders, dementia, etc. of the participant&#xD;
  &#xD;
            -  Previous enrolment into the current study&#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>Christina M Spengler, PhD, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>ETH Zurich, Exercise Physiology Lab, Institute of Human Movement Sciences and Sport</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fernando G Beltrami, PhD</last_name>
      <phone>+41446330472</phone>
      <email>fernando.beltrami@hest.ethz.ch</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Christina M Spengler, PhD, MD</last_name>
      <phone>+41446355007</phone>
      <email>spengler@ethz.ch</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich</name>
        <address>
          <city>Zurich</city>
          <state>ZH</state>
          <zip>8057</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Fernando G Beltrami, PhD</last_name>
        <email>fernando.beltrami@hest.ethz.ch</email>
      </contact>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <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</responsible_party_type>
    </responsible_party>
    <keyword>exercise, cycling, physical activity</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiomyopathies</mesh_term>
      <mesh_term>Arrhythmogenic Right Ventricular Dysplasia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06040242
  org study id: EAP_2020
  nct id: NCT06040242
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Current guidelines advocate that ARVC patients, typically young and active individuals with a
        significant history of competitive endurance sports, cease endurance training in favour of
        activities with low cardiac burden such as bowling and golf. Empirically, it is often
        suggested that heart rate during exercise should not exceed 100-120 bpm in these patients,
        but these guidelines are arbitrary and not scientifically based. In practice, it is estimated
        that up to 50% of patients do not comply with these recommendations .
  
        Adequate quantification of the arrhythmogenic burden, defined as premature ventricular beats
        in proportion to all heart beats in each period of time, and cardiac load (defined as stroke
        volume for volume load and systolic blood pressure for pressure load) experienced by ARVC
        patients when performing different types of physical exercise would be a first step towards
        designing a safe and effective intervention so that these patients can profit from an active
        life style.
  
        This study therefore aims to quantify and describe the arrhythmogenic burden and cardiac load
        experienced by patients with ARVC while performing different physical exercise over a range
        of intensities - all strictly within the range currently recommended by different
        cardiological societies.
  In this study, ARVC patients with different genotypes will perform a series of different
        physical activities, including treadmill walking, cycling at different intensities, biceps
        curls and loaded squats while undergoing extensive cardiovascular monitoring.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: count of premature ventricular beats during and after the activities
  time frame: measured during the 3 min of activity and the 10 min of recovery
  description: as above
  measure: cardiac load during different activities, as rate-pressure product
  time frame: measured during the 3 min of activity
  description: product of heart rate and systolic blood pressure
  measure: cardiac load during different activities, as cardiac output
  time frame: measured during the 3 min of activity
  description: product of heart rate and stroke volume, in L/min
  measure: cardiac load during different activities, as peak blood pressure
  time frame: measured during the 3 min of activity
  description: systolic blood pressure, in mmHg
  arm group label: Patients Group
  arm group type: Experimental
  description: All patients will perform all exercises. Arrhythmogenic activity will compared with that assessed during treadmill walking.
  intervention type: Other
  intervention name: Exercise
  description: Participants will perform 3 min of the different activities, followed by a 10-min recovery window.
  arm group label: Patients Group
  other name: cycling, squats, biceps curls, walking
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Christina M Spengler, PhD, MD
  role: Principal Investigator
  affiliation: ETH Zurich, Exercise Physiology Lab, Institute of Human Movement Sciences and Sport
  last name: Fernando G Beltrami, PhD
  phone: +41446330472
  email: fernando.beltrami@hest.ethz.ch
  last name: Christina M Spengler, PhD, MD
  phone: +41446355007
  email: spengler@ethz.ch
  facility: 
  status: Recruiting
  contact: 
  country: Switzerland
  responsible party type: Sponsor
  mesh term: Cardiomyopathies
  mesh term: Arrhythmogenic Right Ventricular Dysplasia
  sharing ipd: No