<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/NCT04447365</url>
  </required_header>
  <id_info>
    <org_study_id>202001134</org_study_id>
    <nct_id>NCT04447365</nct_id>
  </id_info>
  <brief_title>The Correlation Between Gut Microbiome-host Interaction and Ventricular Arrhythmias.</brief_title>
  <official_title>The Correlation Between Gut Microbiome-host Interaction and Ventricular Arrhythmias.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>North Florida Foundation for Research and Education</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>North Florida Foundation for Research and Education</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 study will enroll 30 subjects recruited from the electrophysiology device clinic at the&#xD;
      VA medical center. All patients will have a pre-existing implantable cardioverter&#xD;
      defibrillator and a diagnosis of cardiomyopathy with left ventricular systolic function of&#xD;
      35% or less by echocardiogram done within 3 years of the time of enrollment. 10 patients who&#xD;
      have had no device-monitored ventricular fibrillation/ ventricular tachycardia for the 3&#xD;
      months prior to recruitment will comprise a group of controls. 20 patients will comprise a&#xD;
      group of patients with high burden of ventricular arrhythmias, defined as patients with at&#xD;
      least one sustained episode of ventricular tachycardia/ ventricular fibrillation requiring&#xD;
      implantable cardioverter-defibrillator therapies in the 3 months preceding study enrollment.&#xD;
      This information will be obtained from device interrogation at the time of recruitment.&#xD;
      Patients will provide a fecal sample for analysis at the time of enrollment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will recruit patient from the VA pacemaker/ implantable cardioverter&#xD;
      defibrillator clinic. Patients with ICDs will be identified before scheduled clinical visit.&#xD;
      Patients whose ICDs on remote monitoring show evidence of VT/VF and who are being admitted to&#xD;
      the VA medical center for expedited inpatient work up and treatment will also be offered&#xD;
      enrollment in the study. Patients will be approached and educated about the study rationale&#xD;
      and their involvement. Patients will be consented for participation in the study after their&#xD;
      approval. Patients will be educated about donating fecal samples. Patients will be given&#xD;
      fecal sampling kits to collect and subsequently mail in those samples to the University of&#xD;
      Florida physiology laboratory where there will be processed in a HIPAA compliant way. These&#xD;
      samples will be subjected to laboratory analysis which will be outsourced. Fecal samples will&#xD;
      be analyzed by shotgun metagenomics to characterize the taxonomy of the gut flora and compare&#xD;
      the taxonomic and physiologic differences between the groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 30, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>high burden arrhythmias</measure>
    <time_frame>initially to 3 months</time_frame>
    <description>: To identify specific gut microbiome characteristics of patients who are prone to clinically significant or high burden of ventricular arrhythmias</description>
  </primary_outcome>
  <primary_outcome>
    <measure>low burden arrhythmias</measure>
    <time_frame>initially to 3 months</time_frame>
    <description>To identify specific gut microbiome characteristics of patients with similar conventional risk factors and low burden of ventricular arrhythmias.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>gut microbiome composition</measure>
    <time_frame>3 months</time_frame>
    <description>: To examine changes that occur in the gut microbiome composition after treatment of ventricular arrhythmias.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Gut Microbiome</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <description>10 patients who have had no device-monitored for ventricular tachycardia/ ventricular fibrillation the 3 months prior to recruitment will comprise a group of controls</description>
  </arm_group>
  <arm_group>
    <arm_group_label>high burden of ventricular arrhythmias</arm_group_label>
    <description>20 patients will comprise a group of patients with high burden of ventricular arrhythmias, defined as patients with at least one sustained episode of VT/VF requiring ICD therapies in the 3 months preceding study enrollment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>device interrogation</intervention_name>
    <description>All patients will have a pre-existing ICD and a diagnosis of cardiomyopathy with left ventricular systolic function of 35% or less by echocardiogram done within 3 years of the time of enrollment.</description>
    <arm_group_label>control</arm_group_label>
    <arm_group_label>high burden of ventricular arrhythmias</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      stool&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Differences in gut microbiome in patients prone to clinically significant ventricular&#xD;
        arrhythmias compared with matched controls with no ventricular arrhythmias. Evaluate&#xD;
        potential clinical implications of the gut microbiome as it relates to ventricular&#xD;
        arrhythmia burden and severity. Patients with an ICD and underlying cardiomyopathy to&#xD;
        analyze fecal samples. The patients with high burden will be re-tested after undergoing a&#xD;
        period of treatment for their arrhythmias and demonstrating a 3 month period wherein there&#xD;
        are no recurrent device therapies. Fecal analysis of the groups will be compared.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • age &gt;18 years-old&#xD;
&#xD;
               -  competent and willing to provide consent&#xD;
&#xD;
               -  presence of implantable cardioverter-defibrillator&#xD;
&#xD;
               -  diagnosis of cardiomyopathy&#xD;
&#xD;
               -  left ventricular ejection fraction of 35% or less as assessed by echocardiogram&#xD;
                  within 3 years prior to enrollment&#xD;
&#xD;
        Inclusion criteria for control group:&#xD;
&#xD;
        • no VT/VF on device interrogation for a period of at least 3 months preceding study&#xD;
        enrollment&#xD;
&#xD;
        Inclusion criteria for high ventricular arrhythmia burden group:&#xD;
&#xD;
        • at least one episode of sustained VT/VF or VT/VF requiring ICD therapies within the&#xD;
        preceding 3 months as assessed on device interrogation at the time of study enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • currently pregnant or have been pregnant in the last 6 months&#xD;
&#xD;
               -  antibiotic treatment within 5 months of study enrollment (i.e. antibiotic therapy&#xD;
                  in the two months prior to the 3-month period of analysis for VT/VF)&#xD;
&#xD;
               -  chronic use of medications/supplements that can potentially affect gut microbiota&#xD;
                  (i.e. probiotics, anti-inflammatory agents, glucocorticoids, other immune&#xD;
                  modulating medications, antacids or proton pump inhibitors)&#xD;
&#xD;
               -  history of intestinal surgery, inflammatory bowel disease, celiac disease,&#xD;
                  lactose intolerance, chronic pancreatitis, or other malabsorption disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ramil Goel, MD</last_name>
    <phone>716-553-3752</phone>
    <email>ramil.goel@va.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cornesia Davis, MPH</last_name>
    <phone>3525486000</phone>
    <phone_ext>104306</phone_ext>
    <email>cornesia.davis@va.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>North Florida/South Georgia Veterans Health System</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>November 9, 2021</last_update_submitted>
  <last_update_submitted_qc>November 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 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>Arrhythmias, Cardiac</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/NCT04447365
org study id: 202001134
nct id: NCT04447365
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will enroll 30 subjects recruited from the electrophysiology device clinic at the
      VA medical center. All patients will have a pre-existing implantable cardioverter
      defibrillator and a diagnosis of cardiomyopathy with left ventricular systolic function of
      35% or less by echocardiogram done within 3 years of the time of enrollment. 10 patients who
      have had no device-monitored ventricular fibrillation/ ventricular tachycardia for the 3
      months prior to recruitment will comprise a group of controls. 20 patients will comprise a
      group of patients with high burden of ventricular arrhythmias, defined as patients with at
      least one sustained episode of ventricular tachycardia/ ventricular fibrillation requiring
      implantable cardioverter-defibrillator therapies in the 3 months preceding study enrollment.
      This information will be obtained from device interrogation at the time of recruitment.
      Patients will provide a fecal sample for analysis at the time of enrollment.
The investigators will recruit patient from the VA pacemaker/ implantable cardioverter
      defibrillator clinic. Patients with ICDs will be identified before scheduled clinical visit.
      Patients whose ICDs on remote monitoring show evidence of VT/VF and who are being admitted to
      the VA medical center for expedited inpatient work up and treatment will also be offered
      enrollment in the study. Patients will be approached and educated about the study rationale
      and their involvement. Patients will be consented for participation in the study after their
      approval. Patients will be educated about donating fecal samples. Patients will be given
      fecal sampling kits to collect and subsequently mail in those samples to the University of
      Florida physiology laboratory where there will be processed in a HIPAA compliant way. These
      samples will be subjected to laboratory analysis which will be outsourced. Fecal samples will
      be analyzed by shotgun metagenomics to characterize the taxonomy of the gut flora and compare
      the taxonomic and physiologic differences between the groups.
observational model: Case-Only
time perspective: Prospective
measure: high burden arrhythmias
time frame: initially to 3 months
description: : To identify specific gut microbiome characteristics of patients who are prone to clinically significant or high burden of ventricular arrhythmias
measure: low burden arrhythmias
time frame: initially to 3 months
description: To identify specific gut microbiome characteristics of patients with similar conventional risk factors and low burden of ventricular arrhythmias.
measure: gut microbiome composition
time frame: 3 months
description: : To examine changes that occur in the gut microbiome composition after treatment of ventricular arrhythmias.
arm group label: control
description: 10 patients who have had no device-monitored for ventricular tachycardia/ ventricular fibrillation the 3 months prior to recruitment will comprise a group of controls
arm group label: high burden of ventricular arrhythmias
description: 20 patients will comprise a group of patients with high burden of ventricular arrhythmias, defined as patients with at least one sustained episode of VT/VF requiring ICD therapies in the 3 months preceding study enrollment.
intervention type: Diagnostic Test
intervention name: device interrogation
description: All patients will have a pre-existing ICD and a diagnosis of cardiomyopathy with left ventricular systolic function of 35% or less by echocardiogram done within 3 years of the time of enrollment.
arm group label: control
arm group label: high burden of ventricular arrhythmias
stool
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ramil Goel, MD
phone: 716-553-3752
email: ramil.goel@va.gov
last name: Cornesia Davis, MPH
phone: 3525486000
phone ext: 104306
email: cornesia.davis@va.gov
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor
mesh term: Arrhythmias, Cardiac
sharing ipd: No