<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20180430039488N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-28</date_registration>
      <primary_sponsor>Tehran Heart Center</primary_sponsor>
      <public_title>Efficacy of steroid treatment on heart blocks secondary to heart valve surgery</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the efficacy of  high dose corticosteroid regimen for treatment of postoperative high degree Atrioventricular block after valvular cardiac surgery ; A single blind randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37399</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: patients in control group receive standard medical care including TPM and monitoring while the others in intervention group receive corticosteroid regimen in addition to standard treatment, Randomization description: permuted block randomization containing 4 subjects in each block eg : AABB. A refers to intervention group and B refers to controls, Blinding description: Collected data of the study will be entered in the SPSS and then analysed by an independent expert from THC research institute.</study_design>
      <phase>3</phase>
      <hc_freetext>Advanced atrioventricular block following heart valve surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Administration of intravenous dexamethasone with dose of 0.4 mg per kg (maximum dose of 35 mg per day) in divided schedule for 3 consecutive days. All patients including control group have the support of temporary pacemaker and standard conservative treatments. Intervention 2: Control group: This group will receive standard treatment protocol including close monitoring of rhythm with support of a Temporary pace maker.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Particular parts of the data will be released

When:
After release of the results

To whom:
Scientific institutions

Conditions:
Further analysis

Where to obtain:
Dr Saeed Ghodsi

How to obtain:
Formal or official request by an institution

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farzad masoud kabir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>North Kargar street,Jala-AL ahmad highway-</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3135674193</zip>
        <telephone>+98 21 8802 9600</telephone>
        <email>Fmasoudkabir@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeed Ghodsi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jala-AL ahmad highway- North Kargar street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3135674193</zip>
        <telephone>+98 21 8802 9600</telephone>
        <email>Dsaeedgh@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Presence of advanced atrioventricular block following heart valve surgery including valve replacement or repair with or without CABG
Written documented informed consent</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Exclusion of patients having cardiac pacemakers or intracardiac defibrilator-cardiovertor or CRT
Exclusion of subjects having prior advanced AV block with underlying congenital or acquired etiologies or known brady-arrhythmia
Exclusion of patients with acute or recent myocardial infarction or  CPR during last week (or survivors of aborted sudden cardiac death)
Exclusion of diabetics with uncontrolled hyperglycemia ( BS&gt;200 in 2 or more measurements out of 4 samples during  last 24 hours or HbA1C&gt;9, ketoacidosis or hyperglycemic hyperosmolar state)
Exclusion of patients with active infections
Exclusion of patients with immune deficiency disorders including malignancies and HIV-AIDS,....
Exclusion of patients with prior history of hypersensitivity reactions to steroids
Exclusion of patients with persistent or permanent atrial fibrillation (AF for more than 24 hours except transient or paroxysmal cases)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>144.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atrioventricular and left bundle-branch block</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Administration of intravenous dexamethasone with dose of 0.4 mg per kg (maximum dose of 35 mg per day) in divided schedule for 3 consecutive days. All patients including control group have the support of temporary pacemaker and standard conservative treatments.</i_keyword>
      <i_keyword>Control group: This group will receive standard treatment protocol including close monitoring of rhythm with support of a Temporary pace maker</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Frequency or recovery of AV block. Timepoint: 5days. Method of measurement: Duration of AV block in hours and percentage of recovery after 5 days.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Incidence rate of of PPM implantation. Timepoint: One month. Method of measurement: Observation and follow-up.Percentage of patients in each group who ultimately undergone PPM implantation.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran Heart Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-08</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Ghods.street, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
