<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/NCT03835494</url>
  </required_header>
  <id_info>
    <org_study_id>Fallot</org_study_id>
    <nct_id>NCT03835494</nct_id>
  </id_info>
  <brief_title>Analysis of RV-Dysfunction in Fallot Patients</brief_title>
  <acronym>Fallot</acronym>
  <official_title>Tissue Doppler Imaging - A Promising Technique To Assess Myocardial Function In Adult Fallot Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Klinik für Kardiologie, Pneumologie und Angiologie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Heinrich-Heine University, Duesseldorf</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>
      In the presented study TDI will be used as a modern technique to characterize RV-function in&#xD;
      Fallot patients at rest and during different exercise conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tissue Doppler imaging (TDI) presents a modern technique to depict the velocity of tissue&#xD;
      motion within a distinct area of the myocardium providing amendatory characterization of&#xD;
      diastolic and systolic function of the heart. TDI is hypothesized to be of additional value&#xD;
      in the evaluation of adult congenital heart disease, especially tetralogy of Fallot (TOF),&#xD;
      which is one of the most common conditions. In particular, Fallot patients are at risk of&#xD;
      developing right ventricular (RV) dysfunction due to pulmonary valve defects or alterations&#xD;
      of the outflow tract. It is pivotal to recognize this progression at an early stage before&#xD;
      irreversible changes occur. Aim of the study is to test feasibility of TDI in Fallot patients&#xD;
      as a new technique that provides new parameters to characterize RV dysfunction, more precise&#xD;
      than common methods. Additionally TDI is performed at rest and during different endurance&#xD;
      testings (passive Leg Raising (PLR), handgrip (HG) and cardiopulmonary exercise (CPX), as&#xD;
      certain changes might be compensated at rest, first apparent during exercise.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">February 28, 2019</completion_date>
  <primary_completion_date type="Actual">February 28, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Transthoracic echocardiography including TDI is performed at rest, during PLR, HG and CPX in Fallot patients and healthy controls. In Fallot patients, transthoracic ultrasound at rest and during CPX are part of the routinely follow-up. PLR and HG were performed additionally as part of the investigator's study to analyze TDI parameters during various endurance testings</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Right ventricular myocardial velocity</measure>
    <time_frame>Baseline</time_frame>
    <description>Right ventricular myocardial velocity during early diastole (cm/s) Right ventricular myocardial velocity during late diastole (cm/s) Right ventricular myocardial velocity during systole (cm/s) baseline (one time point, measurements are performed at rest and during exercise)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peak oxygen consumption (ml/min/kg) and Oxygen consumption at anaerobic threshold (ml/min/kg)</measure>
    <time_frame>Baseline</time_frame>
    <description>CPX is performed for the measurement of TDI velocities at peak exercise, as well as for the assessment of the participants´ cardiopulmonary status. For the latter, the focus lies on oxygen consumption at peak exercise and at anaerobic threshold</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Tetralogy of Fallot</condition>
  <arm_group>
    <arm_group_label>Fallot patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fallot patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy controls</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>healthy volunteers</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Transthoracic echocardiography at rest, during PLR, HG and CPX (including blood gas analysis in both groups). Additionally Fallot patients will undergo routine blood testings.</intervention_name>
    <description>Transthoracic echocardiography at rest, during PLR, HG and CPX (including blood gas analysis in both groups). Additionally Fallot patients will undergo routine blood testings.</description>
    <arm_group_label>Fallot patients</arm_group_label>
    <arm_group_label>healthy controls</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with corrected tetralogy of Fallot&#xD;
&#xD;
          -  Adult healthy controls without cardiovascular disease or other relevant systemic&#xD;
             diseases with written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give written consent, incapable of cycling or handgrip exercise due to&#xD;
             cognitive or orthopedic limitation, poor echocardiographic image quality&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Division of Cardiology, Pulmonary Disease and Vascular Medicine</name>
      <address>
        <city>Düsseldorf</city>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>March 11, 2019</last_update_submitted>
  <last_update_submitted_qc>March 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Heinrich-Heine University, Duesseldorf</investigator_affiliation>
    <investigator_full_name>Klinik für Kardiologie, Pneumologie und Angiologie</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Tetralogy of Fallot</keyword>
  <keyword>Tissue Doppler Imaging</keyword>
  <keyword>Exercise testing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tetralogy of Fallot</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03835494
org study id: Fallot
nct id: NCT03835494
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In the presented study TDI will be used as a modern technique to characterize RV-function in
      Fallot patients at rest and during different exercise conditions.
Tissue Doppler imaging (TDI) presents a modern technique to depict the velocity of tissue
      motion within a distinct area of the myocardium providing amendatory characterization of
      diastolic and systolic function of the heart. TDI is hypothesized to be of additional value
      in the evaluation of adult congenital heart disease, especially tetralogy of Fallot (TOF),
      which is one of the most common conditions. In particular, Fallot patients are at risk of
      developing right ventricular (RV) dysfunction due to pulmonary valve defects or alterations
      of the outflow tract. It is pivotal to recognize this progression at an early stage before
      irreversible changes occur. Aim of the study is to test feasibility of TDI in Fallot patients
      as a new technique that provides new parameters to characterize RV dysfunction, more precise
      than common methods. Additionally TDI is performed at rest and during different endurance
      testings (passive Leg Raising (PLR), handgrip (HG) and cardiopulmonary exercise (CPX), as
      certain changes might be compensated at rest, first apparent during exercise.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Transthoracic echocardiography including TDI is performed at rest, during PLR, HG and CPX in Fallot patients and healthy controls. In Fallot patients, transthoracic ultrasound at rest and during CPX are part of the routinely follow-up. PLR and HG were performed additionally as part of the investigator's study to analyze TDI parameters during various endurance testings
primary purpose: Other
masking: None (Open Label)
measure: Right ventricular myocardial velocity
time frame: Baseline
description: Right ventricular myocardial velocity during early diastole (cm/s) Right ventricular myocardial velocity during late diastole (cm/s) Right ventricular myocardial velocity during systole (cm/s) baseline (one time point, measurements are performed at rest and during exercise)
measure: Peak oxygen consumption (ml/min/kg) and Oxygen consumption at anaerobic threshold (ml/min/kg)
time frame: Baseline
description: CPX is performed for the measurement of TDI velocities at peak exercise, as well as for the assessment of the participants´ cardiopulmonary status. For the latter, the focus lies on oxygen consumption at peak exercise and at anaerobic threshold
arm group label: Fallot patients
arm group type: Experimental
description: Fallot patients
arm group label: healthy controls
arm group type: Experimental
description: healthy volunteers
intervention type: Other
intervention name: Transthoracic echocardiography at rest, during PLR, HG and CPX (including blood gas analysis in both groups). Additionally Fallot patients will undergo routine blood testings.
description: Transthoracic echocardiography at rest, during PLR, HG and CPX (including blood gas analysis in both groups). Additionally Fallot patients will undergo routine blood testings.
arm group label: Fallot patients
arm group label: healthy controls
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: Heinrich-Heine University, Duesseldorf
investigator full name: Klinik für Kardiologie, Pneumologie und Angiologie
investigator title: Principle Investigator
mesh term: Tetralogy of Fallot
sharing ipd: Undecided