<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/NCT02999438</url>
  </required_header>
  <id_info>
    <org_study_id>16060468</org_study_id>
    <nct_id>NCT02999438</nct_id>
  </id_info>
  <brief_title>Frailty in Children With Cardiac Disease</brief_title>
  <official_title>Frailty in Children With Cardiac Disease: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Mercy Hospital Kansas City</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Mercy Hospital Kansas City</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Frailty is a complex biologic syndrome of diminished physiologic reserve that leads to&#xD;
      decreased resistance to stressors and is associated with adverse health outcomes. The&#xD;
      syndrome has been well studied in adults and is quantified by the Fried criteria, which are&#xD;
      comprised of five components- slowness, weakness, self-reported exhaustion, shrinkage and&#xD;
      diminished physical activity. The concept of frailty is novel in children. A study in young&#xD;
      adult childhood cancer survivors demonstrated increased incidence of frailty in this&#xD;
      population along with increased risk of morbidity and mortality. This suggests that frailty&#xD;
      as a phenotype has relevance outside of the geriatric age group. Pediatric patients with&#xD;
      single ventricle physiology, heart failure and pulmonary artery hypertension- all represent&#xD;
      populations with significantly increased risk of mortality, morbidity and decreased quality&#xD;
      of life. Currently, such patients are monitored outpatient by serial echocardiograms and&#xD;
      blood work that only gives information about end organ damage. But there is no validated tool&#xD;
      available to measure global infirmity in such children. Better understanding of the relevance&#xD;
      and applicability of frailty in pediatrics may allow for identification of the most&#xD;
      vulnerable pediatric cardiac patients and be of value in optimizing their clinical management&#xD;
      and improving health outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">October 2022</completion_date>
  <primary_completion_date type="Actual">September 2022</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>Incidence of Frailty in children with hemodynamically significant heart disease</measure>
    <time_frame>1.5 years</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">56</enrollment>
  <condition>Pulmonary Hypertension</condition>
  <condition>Heart Failure</condition>
  <condition>Single Ventricle</condition>
  <arm_group>
    <arm_group_label>Patients with hemodynamically significant heart disease</arm_group_label>
    <description>Patients with either:&#xD;
Single ventricle physiology s/p Fontan&#xD;
Heart failure diagnosed by a cardiologist&#xD;
Pulmonary hypertension diagnosed by cath</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Healthy controls as defined in inclusion- exclusion criteria</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Actigraph to check activity levels at home</intervention_name>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Patients with hemodynamically significant heart disease</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The investigators are studying children with single ventricle physiology, s/p Fontan,&#xD;
        patients with heart failure and pulmonary hypertension.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        SUBJECT/CASE POPULATION herein referred to as Subjects:&#xD;
&#xD;
          -  Children and adolescents between the ages of 8.0-17.50 years&#xD;
&#xD;
          -  Subjects must be diagnosed with one of the following heart conditions:&#xD;
&#xD;
               -  Subjects with single ventricle physiology and Fontan surgery completion at least&#xD;
                  6 months prior to study enrollment&#xD;
&#xD;
               -  Subjects with diagnosis of heart failure by a cardiologist&#xD;
&#xD;
               -  Subjects with a diagnosis of pulmonary arterial hypertension, confirmed by&#xD;
                  cardiac catheterization, requiring use of at least 1 pulmonary vasodilator or&#xD;
                  oxygen for their pulmonary hypertension&#xD;
&#xD;
        CONTROL POPULATION herein referred to as Controls:&#xD;
&#xD;
          -  Healthy children and adolescents between the ages of 8.0-17.50 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        BOTH SUBJECT/CASE POPULATION AND CONTROL POPULATION:&#xD;
&#xD;
          -  Subjects or controls with known severe neurological or respiratory diseases, eating&#xD;
             disorders (such as anorexia, bulimia) or physical limitations (wheelchair bound) which&#xD;
             may impact their ability to perform study procedures in the opinion of the provider.&#xD;
&#xD;
          -  Subjects or controls with tracheostomy and ventilator dependency&#xD;
&#xD;
          -  Subjects or controls with unstable angina/ myocardial infarction in the last 4 weeks&#xD;
&#xD;
          -  Subjects or controls who are unable to perform 6 continuous minutes of walking,&#xD;
             hand-grip dynamometry, or complete questionnaire measures as described.&#xD;
&#xD;
        SUBJECT/ CASE POPULATION:&#xD;
&#xD;
          -  Subjects with heart transplantation within the past 1 year&#xD;
&#xD;
          -  Subject will be excluded if the cardiologist feels that the study is not appropriate&#xD;
             for the subject.&#xD;
&#xD;
        CONTROL POPULATION:&#xD;
&#xD;
          -  Controls with any known chronic medical condition requiring some medication over the&#xD;
             past 30 days.&#xD;
&#xD;
          -  Controls on any chronic prescription medicines for &gt; 30 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian Birnbaum, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Mercy Hospital Kansas City</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Mercy Hospital</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>July 12, 2023</last_update_submitted>
  <last_update_submitted_qc>July 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Mercy Hospital Kansas City</investigator_affiliation>
    <investigator_full_name>Brian Birnbaum</investigator_full_name>
    <investigator_title>Physician, Associate Professor of Pediatrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Univentricular Heart</mesh_term>
    <mesh_term>Frailty</mesh_term>
  </condition_browse>
  <!-- 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/NCT02999438
org study id: 16060468
nct id: NCT02999438
lead sponsor: 
has dmc: No
Frailty is a complex biologic syndrome of diminished physiologic reserve that leads to
      decreased resistance to stressors and is associated with adverse health outcomes. The
      syndrome has been well studied in adults and is quantified by the Fried criteria, which are
      comprised of five components- slowness, weakness, self-reported exhaustion, shrinkage and
      diminished physical activity. The concept of frailty is novel in children. A study in young
      adult childhood cancer survivors demonstrated increased incidence of frailty in this
      population along with increased risk of morbidity and mortality. This suggests that frailty
      as a phenotype has relevance outside of the geriatric age group. Pediatric patients with
      single ventricle physiology, heart failure and pulmonary artery hypertension- all represent
      populations with significantly increased risk of mortality, morbidity and decreased quality
      of life. Currently, such patients are monitored outpatient by serial echocardiograms and
      blood work that only gives information about end organ damage. But there is no validated tool
      available to measure global infirmity in such children. Better understanding of the relevance
      and applicability of frailty in pediatrics may allow for identification of the most
      vulnerable pediatric cardiac patients and be of value in optimizing their clinical management
      and improving health outcomes.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Incidence of Frailty in children with hemodynamically significant heart disease
time frame: 1.5 years
arm group label: Patients with hemodynamically significant heart disease
description: Patients with either:
Single ventricle physiology s/p Fontan
Heart failure diagnosed by a cardiologist
Pulmonary hypertension diagnosed by cath
arm group label: Controls
description: Healthy controls as defined in inclusion- exclusion criteria
intervention type: Device
intervention name: Actigraph to check activity levels at home
arm group label: Controls
arm group label: Patients with hemodynamically significant heart disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Brian Birnbaum, MD
role: Principal Investigator
affiliation: Children's Mercy Hospital Kansas City
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Children's Mercy Hospital Kansas City
investigator full name: Brian Birnbaum
investigator title: Physician, Associate Professor of Pediatrics
mesh term: Hypertension, Pulmonary
mesh term: Heart Diseases
mesh term: Univentricular Heart
mesh term: Frailty