<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/NCT02967315</url>
  </required_header>
  <id_info>
    <org_study_id>2018-0399</org_study_id>
    <secondary_id>2013-0276</secondary_id>
    <secondary_id>SMPH/SURGERY/CARDIOTHORACIC</secondary_id>
    <nct_id>NCT02967315</nct_id>
  </id_info>
  <brief_title>Effects of Changes in Fluid Status on Right Ventricular Volumes and Function</brief_title>
  <official_title>Effects of Changes in Fluid Status on Right Ventricular Volumes and Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the correlation between fluid volume status and&#xD;
      right ventricular volume and function, in those with free pulmonary valve insufficiency after&#xD;
      Tetralogy of Fallot (TOF) repair.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to measure the changes in Right Ventricular size and function&#xD;
      with changes in preload, using cardiovascular magnetic resonance (CMR). Based on an intensive&#xD;
      research and clinical observations the investigators hypothesize that changes in volume&#xD;
      status cause a statistically significant difference in the Cardiovascular magnetic resonance&#xD;
      (CMR) measured RV End Diastolic Volume (EDV), end-systolic volume (ESV), ejection fraction&#xD;
      (EF) and pulmonary regurgitation (PR). The investigator hypothesizes that smaller changes&#xD;
      will occur in left ventricular LV EDV, ESV, and EF.&#xD;
&#xD;
        1. To establish a correlation between the changes in preload volume status and RV size and&#xD;
           function in patients with free pulmonary insufficiency (PI) after TOF repair using CMRI.&#xD;
&#xD;
        2. To assess the effects of preload status on the measured severity of pulmonary&#xD;
           regurgitation (PR).&#xD;
&#xD;
        3. To assess the effects of preload status on the left ventricular (LV) size&#xD;
&#xD;
      This study will be conducted in compliance with this protocol, good clinical practice and the&#xD;
      applicable regulatory requirements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 6, 2014</start_date>
  <completion_date type="Actual">March 18, 2021</completion_date>
  <primary_completion_date type="Actual">March 18, 2021</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postload volume status</measure>
    <time_frame>24 months</time_frame>
    <description>The following will be measured to define the postload volume status: Left and right ventricle end diastolic volume (milliliters [ml]); Ejection fraction (%); pulmonary regurgitation</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Tetralogy of Fallot</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Procedures include:&#xD;
Two Cardiac Magnetic Resonance Imaging (CMRIs) A central venous line placement, A chest X-ray Electrocardiogram (ECG) Fluid administration Blood draw Pregnancy test</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cardiac Magnetic Resonance Imaging (CMRI)</intervention_name>
    <description>There will be 2 CMRIs. The first one will be patient's routine clinically schedule CMRI after the patient has fasted for 12 hours.This CMRI uses contrast.&#xD;
The second CMRI will be the research CMRI after the fluid administration. This CMRI does not use contrast.</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Central venous line placement</intervention_name>
    <description>An ultrasound guided central line catheter will be placed in the internal jugular vein (IJV) under local anesthesia.</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Chest X-ray</intervention_name>
    <description>A chest X-ray will be performed for safety reasons to rule out pneumothorax (&lt; 1% risk) after central line placement.</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fluid administration</intervention_name>
    <description>Administration of 15cc/kg of normal saline for fluid hydration through peripheral IV that is placed for the MRI contrast administration.</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood Draw</intervention_name>
    <description>One to two teaspoons of blood will be drawn for basic metabolic panel.</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pregnancy test</intervention_name>
    <description>A urine pregnancy test will be performed in female subjects.</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Electrocardiogram</intervention_name>
    <description>12 lead ECG</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. TOF patients who have had repair using a transannular patch.&#xD;
&#xD;
          2. Patients that present with free pulmonary insufficiency.&#xD;
&#xD;
          3. Are older than 18 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who have lesions predisposing to chronic volume overload (i.e. patients with&#xD;
             significant residual postoperative ventricular septal defects (VSD), or large&#xD;
             aorto-pulmonary collaterals or more than moderate tricuspid insufficiency) since all&#xD;
             these hemodynamic conditions can influence the late function of the right ventricle&#xD;
             and potentially affect the response of the right side of the heart in changes in&#xD;
             volume status&#xD;
&#xD;
          2. Patients who had a valve sparing TOF repair and have less than free pulmonary&#xD;
             insufficiency.&#xD;
&#xD;
          3. Patients who have significant residual right-sided obstruction (i.e. patients who have&#xD;
             residual RVOT obstruction or significant residual branch pulmonary artery stenosis),&#xD;
             as it is shown that residual pulmonary stenosis may protect from RV dilation and from&#xD;
             deterioration of the RV function.&#xD;
&#xD;
          4. Patients who cannot be reconstructed with a transannular patch and/or require a right&#xD;
             ventricle to pulmonary artery homograft for reconstruction including:&#xD;
&#xD;
               -  pulmonary atresia and VSD&#xD;
&#xD;
               -  patients with anomalous coronary crossing the right ventricular outflow tract&#xD;
                  (RVOT) and&#xD;
&#xD;
               -  patients with TOF-absent pulmonary valve syndrome.&#xD;
&#xD;
          5. Patients with renal failure and renal insufficiency&#xD;
&#xD;
          6. Patients with uncompensated heart failure&#xD;
&#xD;
          7. Cancer patients&#xD;
&#xD;
          8. Latex allergic patients&#xD;
&#xD;
          9. Patients with diabetes&#xD;
&#xD;
         10. Pregnant females&#xD;
&#xD;
         11. Prisoners&#xD;
&#xD;
         12. Individuals who lack consent capacity&#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>Petros V Anagnostopoulos, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin-Madison</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>October 27, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>April 9, 2021</last_update_submitted>
  <last_update_submitted_qc>April 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>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/NCT02967315
org study id: 2018-0399
secondary id: 2013-0276
secondary id: SMPH/SURGERY/CARDIOTHORACIC
nct id: NCT02967315
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the correlation between fluid volume status and
      right ventricular volume and function, in those with free pulmonary valve insufficiency after
      Tetralogy of Fallot (TOF) repair.
The purpose of this study is to measure the changes in Right Ventricular size and function
      with changes in preload, using cardiovascular magnetic resonance (CMR). Based on an intensive
      research and clinical observations the investigators hypothesize that changes in volume
      status cause a statistically significant difference in the Cardiovascular magnetic resonance
      (CMR) measured RV End Diastolic Volume (EDV), end-systolic volume (ESV), ejection fraction
      (EF) and pulmonary regurgitation (PR). The investigator hypothesizes that smaller changes
      will occur in left ventricular LV EDV, ESV, and EF.

        1. To establish a correlation between the changes in preload volume status and RV size and
           function in patients with free pulmonary insufficiency (PI) after TOF repair using CMRI.

        2. To assess the effects of preload status on the measured severity of pulmonary
           regurgitation (PR).

        3. To assess the effects of preload status on the left ventricular (LV) size

      This study will be conducted in compliance with this protocol, good clinical practice and the
      applicable regulatory requirements.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Postload volume status
time frame: 24 months
description: The following will be measured to define the postload volume status: Left and right ventricle end diastolic volume (milliliters [ml]); Ejection fraction (%); pulmonary regurgitation
arm group label: Study Group
arm group type: Experimental
description: Procedures include:
Two Cardiac Magnetic Resonance Imaging (CMRIs) A central venous line placement, A chest X-ray Electrocardiogram (ECG) Fluid administration Blood draw Pregnancy test
intervention type: Procedure
intervention name: Cardiac Magnetic Resonance Imaging (CMRI)
description: There will be 2 CMRIs. The first one will be patient's routine clinically schedule CMRI after the patient has fasted for 12 hours.This CMRI uses contrast.
The second CMRI will be the research CMRI after the fluid administration. This CMRI does not use contrast.
arm group label: Study Group
intervention type: Procedure
intervention name: Central venous line placement
description: An ultrasound guided central line catheter will be placed in the internal jugular vein (IJV) under local anesthesia.
arm group label: Study Group
intervention type: Procedure
intervention name: Chest X-ray
description: A chest X-ray will be performed for safety reasons to rule out pneumothorax (< 1% risk) after central line placement.
arm group label: Study Group
intervention type: Procedure
intervention name: Fluid administration
description: Administration of 15cc/kg of normal saline for fluid hydration through peripheral IV that is placed for the MRI contrast administration.
arm group label: Study Group
intervention type: Procedure
intervention name: Blood Draw
description: One to two teaspoons of blood will be drawn for basic metabolic panel.
arm group label: Study Group
intervention type: Procedure
intervention name: Pregnancy test
description: A urine pregnancy test will be performed in female subjects.
arm group label: Study Group
intervention type: Procedure
intervention name: Electrocardiogram
description: 12 lead ECG
arm group label: Study Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Petros V Anagnostopoulos, MD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tetralogy of Fallot
sharing ipd: No