<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/NCT03289429</url>
  </required_header>
  <id_info>
    <org_study_id>Statin and Magnesium</org_study_id>
    <nct_id>NCT03289429</nct_id>
  </id_info>
  <brief_title>Antiarrhythmic and Cardioprotective Effects of Atorvastatin Versus Magnesium Sulfate in Cardiac Valve Replacement Surgery</brief_title>
  <official_title>Comparative Study of the Antiarrhythmic and Cardioprotective Effects of Atorvastatin Versus Magnesium Sulfate in Cardiac Valve Replacement Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      This study aims to compare the antiarrhythmic and cardioprotective effects of Atorvastatin&#xD;
      versus Magnesium Sulfate after Cardiac valve Replacement Surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Arrhythmia is a common complication after cardiac valve surgery. Postoperative atrial&#xD;
      fibrillation (POAF) is the most common type of arrhythmia after cardiac surgery. It has&#xD;
      different leading causes, including myocardial injury, inadequate myocardial protection, the&#xD;
      effect of cardiopulmonary bypass, and electrolyte imbalance. Beta blockers, amiodarone, and&#xD;
      magnesium sulfate are used for the management of POAF.&#xD;
&#xD;
      Statin is used commonly for its lipid lowering action, however, some studies shows that&#xD;
      statin has powerful pleiotropic effects including its antiarrhythmic effect.&#xD;
&#xD;
      This study aims to compare the antiarrhythmic and cardioprotective effects of Atorvastatin&#xD;
      versus magnesium sulfate after cardiac replacement surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 24, 2017</start_date>
  <completion_date type="Anticipated">February 2018</completion_date>
  <primary_completion_date type="Anticipated">February 2018</primary_completion_date>
  <phase>Phase 4</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative atrial fibrillation</measure>
    <time_frame>Five days</time_frame>
    <description>The occurrence of postoperative atrial fibrillation (POAF)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Arrhythmias</condition>
  <arm_group>
    <arm_group_label>Atorvastatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Atorvastatin and intravenous placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Magnesium sulfate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Magnesium sulfate and tablets placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>intravenous placebo and tablet placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin</intervention_name>
    <description>Atorvastatin in a dose of 80 mgs, twelve hours preoperatively, two hours preoperatively, and on the 2nd, 3rd, 4th and 5th postoperative days.</description>
    <arm_group_label>Atorvastatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Magnesium Sulfate</intervention_name>
    <description>Magnesium sulfate: ( 3 grams dissolved in 100 mL of isotonic saline to be infused over 2 hours) twelve hours preoperatively, within the first hour of ICU arrival, and on the 2nd and 3rd postoperative days.</description>
    <arm_group_label>Magnesium sulfate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>intravenous placebo</intervention_name>
    <description>100 mL of isotonic saline (to be infused over 2 hours) twelve hours preoperatively, within the first hour of ICU arrival, and on the 2nd and 3rd postoperative days.</description>
    <arm_group_label>Atorvastatin</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>tablets placebo</intervention_name>
    <description>Placebo tablets: twelve hours preoperatively, two hours preoperatively, and on the 2nd, 3rd, 4th and 5th postoperative days.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Magnesium sulfate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing isolated valvular replacement surgery.&#xD;
&#xD;
          -  Preoperative rhythm: Sinus rhythm.&#xD;
&#xD;
          -  Preoperative troponin I &lt; 0.01 ng/mL.&#xD;
&#xD;
          -  Normal lipid profile.&#xD;
&#xD;
          -  White blood cells (4-11 X 103/mm3).&#xD;
&#xD;
          -  Preoperative C-reactive protein &lt; 3 mg/L.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of atrial fibrillation.&#xD;
&#xD;
          -  Any degree of heart block or patients with implanted pacemaker.&#xD;
&#xD;
          -  Prior use of Antiarrhythmic drugs.&#xD;
&#xD;
          -  Preoperative lipid lowering therapy (e.g statins) during the last 3 months.&#xD;
&#xD;
          -  Previous treatment with any type of magnesium containing supplementation (the week&#xD;
             before the intervention).&#xD;
&#xD;
          -  Underlying heart failure or Left ventricular ejection fraction &lt; 0.3.&#xD;
&#xD;
          -  Previous myocardial infarction.&#xD;
&#xD;
          -  Diabetes or other metabolic disorders.&#xD;
&#xD;
          -  Renal diseases.&#xD;
&#xD;
          -  Hepatic dysfunction.&#xD;
&#xD;
          -  Underlying thyroid problems (hypo/hyperthyroidism).&#xD;
&#xD;
          -  Underlying inflammatory disease (active or controlled)&#xD;
&#xD;
          -  Immunosuppressive and anti-inflammatory medications for the treatment of coexisting&#xD;
             conditions.&#xD;
&#xD;
          -  Psychological disorders,&#xD;
&#xD;
          -  Emergency cardiac surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Assiut University</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fatma N. Mohamed, M.Sc.</last_name>
      <phone>+201003633992</phone>
      <email>fatmanabil2012@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Esam Eldin M. Abdallah, M.D.</last_name>
      <email>esamel_deen@yahoo.com</email>
    </contact_backup>
    <investigator>
      <last_name>Fatma N. Mohamed, M.Sc.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Esam Eldin M. Abdallah, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Abdelrady S. Ibrahim, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ahmed El-Minshawy, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>February 10, 2018</last_update_submitted>
  <last_update_submitted_qc>February 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>FATMA NABIL AHMED MOHAMED</investigator_full_name>
    <investigator_title>Assistant lecturer of anesthesia and intensive care, Assiut University</investigator_title>
  </responsible_party>
  <keyword>Atorvastatin</keyword>
  <keyword>Magnesium sulfate</keyword>
  <keyword>POAF</keyword>
  <keyword>Cardiac</keyword>
  <keyword>Valve</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Magnesium Sulfate</mesh_term>
    <mesh_term>Atorvastatin</mesh_term>
  </intervention_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/NCT03289429
org study id: Statin and Magnesium
nct id: NCT03289429
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aims to compare the antiarrhythmic and cardioprotective effects of Atorvastatin
      versus Magnesium Sulfate after Cardiac valve Replacement Surgery
Arrhythmia is a common complication after cardiac valve surgery. Postoperative atrial
      fibrillation (POAF) is the most common type of arrhythmia after cardiac surgery. It has
      different leading causes, including myocardial injury, inadequate myocardial protection, the
      effect of cardiopulmonary bypass, and electrolyte imbalance. Beta blockers, amiodarone, and
      magnesium sulfate are used for the management of POAF.

      Statin is used commonly for its lipid lowering action, however, some studies shows that
      statin has powerful pleiotropic effects including its antiarrhythmic effect.

      This study aims to compare the antiarrhythmic and cardioprotective effects of Atorvastatin
      versus magnesium sulfate after cardiac replacement surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Postoperative atrial fibrillation
time frame: Five days
description: The occurrence of postoperative atrial fibrillation (POAF)
arm group label: Atorvastatin
arm group type: Experimental
description: Atorvastatin and intravenous placebo
arm group label: Magnesium sulfate
arm group type: Experimental
description: Magnesium sulfate and tablets placebo
arm group label: Control
arm group type: Placebo Comparator
description: intravenous placebo and tablet placebo
intervention type: Drug
intervention name: Atorvastatin
description: Atorvastatin in a dose of 80 mgs, twelve hours preoperatively, two hours preoperatively, and on the 2nd, 3rd, 4th and 5th postoperative days.
arm group label: Atorvastatin
intervention type: Drug
intervention name: Magnesium Sulfate
description: Magnesium sulfate: ( 3 grams dissolved in 100 mL of isotonic saline to be infused over 2 hours) twelve hours preoperatively, within the first hour of ICU arrival, and on the 2nd and 3rd postoperative days.
arm group label: Magnesium sulfate
intervention type: Other
intervention name: intravenous placebo
description: 100 mL of isotonic saline (to be infused over 2 hours) twelve hours preoperatively, within the first hour of ICU arrival, and on the 2nd and 3rd postoperative days.
arm group label: Atorvastatin
arm group label: Control
intervention type: Other
intervention name: tablets placebo
description: Placebo tablets: twelve hours preoperatively, two hours preoperatively, and on the 2nd, 3rd, 4th and 5th postoperative days.
arm group label: Control
arm group label: Magnesium sulfate
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: FATMA NABIL AHMED MOHAMED
investigator title: Assistant lecturer of anesthesia and intensive care, Assiut University
mesh term: Arrhythmias, Cardiac
mesh term: Magnesium Sulfate
mesh term: Atorvastatin