<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/NCT03263312</url>
  </required_header>
  <id_info>
    <org_study_id>STU 122016-037</org_study_id>
    <nct_id>NCT03263312</nct_id>
  </id_info>
  <brief_title>Multimodality Biomarkers for Noninvasive Assessment of the Fontan Patient</brief_title>
  <official_title>Multimodality Biomarkers for Noninvasive Assessment of the Fontan Patient</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maria Bano</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Medical Center Dallas</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 is a single center prospective longitudinal exercise training study and will enroll&#xD;
      approximately 50 Fontan patients and 20 controls of a similar age, gender, BMI and physical&#xD;
      activity level between the ages of 10-40 years.&#xD;
&#xD;
      Participants will undergo an MRI of the Fontan circulation. This will include imaging of the&#xD;
      heart, lung and liver. This will include specific imaging for tissue characterization and&#xD;
      assessment of myocardial fibrosis, liver fibrosis and disproportionate pulmonary blood flow.&#xD;
      The investigators will then draw blood (approximately 10 ml) for assessment of serum&#xD;
      biomarkers and circulating microRNAs of interest. The participants will undergo exercise&#xD;
      testing and will then start a 3-6 month long cardiac rehabilitation program. After the 3-6&#xD;
      month study period the participants will return back for a follow up and repeat all the&#xD;
      testing completed at enrollement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single center prospective longitudinal study and will enroll approximately 50&#xD;
      Fontan patients and 20 controls of a similar age, gender, BMI and physical activity level&#xD;
      between the ages of 10-40 years. The investigators will enroll from pediatric cardiology and&#xD;
      heart failure clinics and inpatient care units at Children's Health Dallas, adult congenital&#xD;
      heart disease clinics and inpatient care units at Clements University Hospital and the&#xD;
      Clinical Heart Center. This study will evaluate the multimodality biomarkers for assessment&#xD;
      of Fontan circulation including heart, liver and lung and change in these markers with&#xD;
      exercise training.&#xD;
&#xD;
      Participants will receive an MRI of the Fontan circulation. This will include imaging of the&#xD;
      heart, lung and liver. A blood draw (approximately 10 ml) for assessment of serum biomarkers&#xD;
      and circulating microRNAs of interest will be completed. The participants will also complete&#xD;
      exercise testing and will then start a 3-6 month long cardiac rehabilitation program.&#xD;
      Frequent phone follow up (conducted by the research staff) and regular download of data from&#xD;
      heart rate monitors will ensure adherence.&#xD;
&#xD;
      After the 3-6 month study period the participants will return for a follow up and repeat all&#xD;
      testing completed at enrollment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">June 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak VO2</measure>
    <time_frame>6 months</time_frame>
    <description>Improvement in Peak VO2 with 6 months of exercise training</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Single-ventricle</condition>
  <condition>Myocardial Fibrosis</condition>
  <arm_group>
    <arm_group_label>Fontan Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All Fontan patients included in this study will be part of an exercise intervention 2-6 times/week for 3-6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Exercise training all patients enrolled.</description>
    <arm_group_label>Fontan Patients</arm_group_label>
    <other_name>Training</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of a congenital heart defect that leads to single ventricle physiology&#xD;
&#xD;
          -  Previously performed TCPA surgery&#xD;
&#xD;
          -  Current age 10 years to 40 years&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of exercise intolerance (peak VO2&lt;12ml/kg/min)&#xD;
&#xD;
          -  Unstable arrhythmia at the time of screening&#xD;
&#xD;
          -  Listed or being evaluated for heart transplantation&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Patient with pacemaker, AV block other than 1st degree block, sick sinus syndrome or&#xD;
             other arrhythmia that may influence ability to perform exercise test or magnetic&#xD;
             resonance imaging&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Children'sMCD</name>
      <address>
        <city>Irving</city>
        <state>Texas</state>
        <zip>75063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>September 2, 2021</last_update_submitted>
  <last_update_submitted_qc>September 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Children's Medical Center Dallas</investigator_affiliation>
    <investigator_full_name>Maria Bano</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>myocardial fibrosis</keyword>
  <keyword>exercise training</keyword>
  <keyword>Fontan</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Univentricular Heart</mesh_term>
    <mesh_term>Fibrosis</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/NCT03263312
org study id: STU 122016-037
nct id: NCT03263312
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a single center prospective longitudinal exercise training study and will enroll
      approximately 50 Fontan patients and 20 controls of a similar age, gender, BMI and physical
      activity level between the ages of 10-40 years.

      Participants will undergo an MRI of the Fontan circulation. This will include imaging of the
      heart, lung and liver. This will include specific imaging for tissue characterization and
      assessment of myocardial fibrosis, liver fibrosis and disproportionate pulmonary blood flow.
      The investigators will then draw blood (approximately 10 ml) for assessment of serum
      biomarkers and circulating microRNAs of interest. The participants will undergo exercise
      testing and will then start a 3-6 month long cardiac rehabilitation program. After the 3-6
      month study period the participants will return back for a follow up and repeat all the
      testing completed at enrollement.
This is a single center prospective longitudinal study and will enroll approximately 50
      Fontan patients and 20 controls of a similar age, gender, BMI and physical activity level
      between the ages of 10-40 years. The investigators will enroll from pediatric cardiology and
      heart failure clinics and inpatient care units at Children's Health Dallas, adult congenital
      heart disease clinics and inpatient care units at Clements University Hospital and the
      Clinical Heart Center. This study will evaluate the multimodality biomarkers for assessment
      of Fontan circulation including heart, liver and lung and change in these markers with
      exercise training.

      Participants will receive an MRI of the Fontan circulation. This will include imaging of the
      heart, lung and liver. A blood draw (approximately 10 ml) for assessment of serum biomarkers
      and circulating microRNAs of interest will be completed. The participants will also complete
      exercise testing and will then start a 3-6 month long cardiac rehabilitation program.
      Frequent phone follow up (conducted by the research staff) and regular download of data from
      heart rate monitors will ensure adherence.

      After the 3-6 month study period the participants will return for a follow up and repeat all
      testing completed at enrollment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Peak VO2
time frame: 6 months
description: Improvement in Peak VO2 with 6 months of exercise training
arm group label: Fontan Patients
arm group type: Experimental
description: All Fontan patients included in this study will be part of an exercise intervention 2-6 times/week for 3-6 months.
intervention type: Behavioral
intervention name: Exercise
description: Exercise training all patients enrolled.
arm group label: Fontan Patients
other name: Training
criteria: 
gender: All
minimum age: 10 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Children's Medical Center Dallas
investigator full name: Maria Bano
investigator title: Assistant Professor
mesh term: Univentricular Heart
mesh term: Fibrosis
sharing ipd: No