xml: <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/NCT05993897</url>
    </required_header>
    <id_info>
      <org_study_id>693/11/22</org_study_id>
      <nct_id>NCT05993897</nct_id>
    </id_info>
    <brief_title>Effect of Sodium Glucose Co-transporter 2 Inhibitors on Left Atrial Remodeling</brief_title>
    <official_title>Effect of Sodium Glucose Co-transporter 2 Inhibitors on Left Atrium Remodeling in Non-valvular Paroxysmal Atrial Fibrillation Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aswan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Aswan University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Investigators are going to assess direct effect of SGLT2 inhibitors on left atrial remodeling&#xD;
        in participants with nonvalvular paroxysmal atrial fibrillation regardless of diabetes&#xD;
        status.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Left atrial remodeling</measure>
      <time_frame>Before first administration of treatment and will be repeated 6 months after while still on treatment</time_frame>
      <description>by measuring Indexed LA volume (LAVI) in ml/m2</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in left atrial strain</measure>
      <time_frame>Before first administration of treatment and will be repeated 6 months after while still on treatment</time_frame>
      <description>by measuring left atrial strain %</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in left atrial systolic force</measure>
      <time_frame>Before first administration of treatment and will be repeated 6 months after while still on treatment</time_frame>
      <description>by measuring left atrial systolic force in ml/m3</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mean percentage of time spent in atrial fibrillation</measure>
      <time_frame>After the first dose of treatment till the end of the study (1 year)</time_frame>
      <description>By documented ECG or Holter monitoring</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mortality Rate</measure>
      <time_frame>After the first dose of treatment till the end of the study (1 year)</time_frame>
      <description>all cause mortality</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Hospitalization due to HF</measure>
      <time_frame>After the first dose of treatment till the end of the study (1 year)</time_frame>
      <description>In hospital admission by HF symptoms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with Stroke</measure>
      <time_frame>After the first dose of treatment till the end of the study (1 year)</time_frame>
      <description>Ischemic or hemorrhagic</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Atrial Fibrillation</condition>
    <arm_group>
      <arm_group_label>Dapagliflozin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>patients who will receive SGLT2 inhibitors</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Patients who will receive Rhythm control +/- oral anticoagulation</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor</intervention_name>
      <description>10 mg of Dapagliflozin orally once daily</description>
      <arm_group_label>Dapagliflozin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Rhythm control and anticoagulation</intervention_name>
      <description>In acute stage: Cardioversion with D.C shock if haemodynamically unstable, after failure of pharmacological cardioversion or participant preference.&#xD;
  or pharmacological cardioversion with either IV cordarone in structurally abnormal heart (150mg over 10 minutes followed by1 mg/min infusion for 6 hours followed by 0.5 mg/min not exceeding 2.4 grams over 24 hours till restoration of sinus Rhythm. Then maintenance dose of 200 mg tab orally every 8 hours for 3 weeks then 200 mg tab orally once per day.&#xD;
  or Propafenone (Rytmonorm) 600 mg single oral dose in structurally normal heart then maintenance dose of 150mg tab orally every 8 hours.&#xD;
  + Rivaroxaban 20mg orally once daily if CHA2DS2 VASc score 1 or more for males and 2 or more for females.</description>
      <arm_group_label>Dapagliflozin</arm_group_label>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. with non-valvular paroxysmal atrial fibrillation (AF that terminates spontaneously or&#xD;
               with intervention within seven days of onset).&#xD;
  &#xD;
            2. Patient age 18-60 years.&#xD;
  &#xD;
            3. Patients with Glomerular Filtration Rate (GFR) &gt;45 ml/min/1.73m2 (Cockcroft-Gault&#xD;
               equation).&#xD;
  &#xD;
            4. Patient with normal left atrium or dilated (diameter &lt;5 cm)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients &lt; 18 yrs old.&#xD;
  &#xD;
            2. Patients with valvular heart diseases (Moderate to severe MS, severe AS, Prosthetic&#xD;
               heart valves).&#xD;
  &#xD;
            3. Patients with left atrium &gt; 5cm.&#xD;
  &#xD;
            4. Patients with glomerular Filtration Rate (GFR) &lt;45 ml/min/1.73m2 (Cockcroft-Gault&#xD;
               equation).&#xD;
  &#xD;
            5. Patient with ischemic heart disease (previous MI, UA, PCI or CABG).&#xD;
  &#xD;
            6. Patient with previous ischemic stroke.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Aswan University</investigator_affiliation>
      <investigator_full_name>Aml Soliman</investigator_full_name>
      <investigator_title>Lecturer of cardiology, Aswan university</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Atrial Fibrillation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05993897
  org study id: 693/11/22
  nct id: NCT05993897
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Investigators are going to assess direct effect of SGLT2 inhibitors on left atrial remodeling
        in participants with nonvalvular paroxysmal atrial fibrillation regardless of diabetes
        status.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Left atrial remodeling
  time frame: Before first administration of treatment and will be repeated 6 months after while still on treatment
  description: by measuring Indexed LA volume (LAVI) in ml/m2
  measure: Changes in left atrial strain
  time frame: Before first administration of treatment and will be repeated 6 months after while still on treatment
  description: by measuring left atrial strain %
  measure: Changes in left atrial systolic force
  time frame: Before first administration of treatment and will be repeated 6 months after while still on treatment
  description: by measuring left atrial systolic force in ml/m3
  measure: Mean percentage of time spent in atrial fibrillation
  time frame: After the first dose of treatment till the end of the study (1 year)
  description: By documented ECG or Holter monitoring
  measure: Mortality Rate
  time frame: After the first dose of treatment till the end of the study (1 year)
  description: all cause mortality
  measure: Incidence of Hospitalization due to HF
  time frame: After the first dose of treatment till the end of the study (1 year)
  description: In hospital admission by HF symptoms
  measure: Number of participants with Stroke
  time frame: After the first dose of treatment till the end of the study (1 year)
  description: Ischemic or hemorrhagic
  arm group label: Dapagliflozin
  arm group type: Active Comparator
  description: patients who will receive SGLT2 inhibitors
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Patients who will receive Rhythm control +/- oral anticoagulation
  intervention type: Drug
  intervention name: Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor
  description: 10 mg of Dapagliflozin orally once daily
  arm group label: Dapagliflozin
  intervention type: Drug
  intervention name: Rhythm control and anticoagulation
  description: In acute stage: Cardioversion with D.C shock if haemodynamically unstable, after failure of pharmacological cardioversion or participant preference.
  or pharmacological cardioversion with either IV cordarone in structurally abnormal heart (150mg over 10 minutes followed by1 mg/min infusion for 6 hours followed by 0.5 mg/min not exceeding 2.4 grams over 24 hours till restoration of sinus Rhythm. Then maintenance dose of 200 mg tab orally every 8 hours for 3 weeks then 200 mg tab orally once per day.
  or Propafenone (Rytmonorm) 600 mg single oral dose in structurally normal heart then maintenance dose of 150mg tab orally every 8 hours.
  + Rivaroxaban 20mg orally once daily if CHA2DS2 VASc score 1 or more for males and 2 or more for females.
  arm group label: Dapagliflozin
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Aswan University
  investigator full name: Aml Soliman
  investigator title: Lecturer of cardiology, Aswan university
  mesh term: Atrial Fibrillation
  sharing ipd: No