<?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>IRCT20190806044451N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-07</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of empagliflozin on improvement of hematopeosis in diabetic cardiovascular patient</public_title>
      <acronym></acronym>
      <scientific_title>The effect of empagliflozin on serum erythropoietin level ,hematopoietic indices indices and the positive short term echocardiographic changes in type 2 diabetic patients with coronary artery disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42051</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method in this study is simple randomization and the randomization unit is also individual. People in this study will be divided into two groups without specific bias, Blinding description: Patients are divided into two groups of intervention and control by the person who has no role in the process of execution and analysis of the data, and the drug and placebo are given after initial prototyping and cardiac echocardiography.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Diabetes Mellitus type 2. Condition 2: Coronary artery disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Diabetic patients with proven cardiovascular disease will be treated with a 10 mg dose of ampogliflozin at a six-month interval in addition to their previous treatment. Intervention 2: Control group: Patients in the control group are diabetic patients with proven cardiovascular disease who receive placebo over a six-month period in addition to their previous treatments.</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:
After analyzing the data and defending the thesis, an article is sent to a reputable journal with the patient information retained for publication.

When:
From 2020- on wards the basis of the letter of the publisher magazine

To whom:
All members of the medical community

Conditions:
In coordination with the responsible person and in writing and with the consent of the patients

Where to obtain:
To the email or mobile phone number of the responsible person

How to obtain:
After publishing an article in a prestigious journal, it is decided on the basis of the journal's letter

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Reyhaneh Mahmoodian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati Blvd</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515777978</zip>
        <telephone>+98 24 3377 0758</telephone>
        <email>Metabolic1397@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Reyhaneh Mahmoodian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zanjan - Metabolic Center of Valiasr Hospital</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515777978</zip>
        <telephone>+98 24 3377 0758</telephone>
        <email>reyhanehmahmoodian@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>type2 diabetes
age more than 40
stablished cardiovascular disease with angiography
HbA1c between 7 to 9</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>heart failure (EF&lt;40 %)
history of myocardial infarction or un stable angina during 6 month ago
Recent anemia
severe kidney disease(GFR&lt;30)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
      <hc_code>I125.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus</hc_keyword>
      <hc_keyword>Atherosclerotic heart disease of native coronary artery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Diabetic patients with proven cardiovascular disease will be treated with a 10 mg dose of ampogliflozin at a six-month interval in addition to their previous treatment.</i_keyword>
      <i_keyword>Control group: Patients in the control group are diabetic patients with proven cardiovascular disease who receive placebo over a six-month period in addition to their previous treatments.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Duration of illness. Timepoint: six month. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Drug history. Timepoint: six month. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Empagliflozine. Timepoint: period six month. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Erythropoetin level. Timepoint: six month. Method of measurement: ELAISA.</prim_outcome>
      <prim_outcome>Spot albumin to Cr. Timepoint: six month. Method of measurement: dip stick.</prim_outcome>
      <prim_outcome>Serum hemoglobin levels before and after treatment. Timepoint: six month. Method of measurement: immunoichemilosent.</prim_outcome>
      <prim_outcome>Echocardiography. Timepoint: six month. Method of measurement: echocardiography device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>1. Evaluation of changes in serum erythropoietin levels before and after the use of impagliflozin compared with placebo in diabetic patients with stable cardiovascular disease2. Evaluation of the relationship between changes in serum erythropoietin level and changes in hematopoietic indexes before and after the use of ampogliflozin compared with placebo in diabetic patients with stable cardiovascular disease3. Evaluation of the relationship between changes in serum erythropoietin level and Alb / cr changes before and after the use of ampoglifluosine compared with placebo in diabetic patients with stable cardiovascular disease4. Evaluation of the relationship between changes in serum erythropoietin level and the magnitude of changes in echocardiographic indices before and after the use of ampogliflozin compared with placebo in diabetic patients with stable cardiovascular disease5. Evaluation of the relationship between changes in FBS, HbA1c and serum levels of erythropoietin before and after the use of ampogliflosin compared with placebo in diabetic patients with stable cardiovascular disease6. Evaluation of fasting serum insulin level in patients taking oral hypoglycemic drugs before and after impagliflozin compared with placebo in diabetic patients with stable cardiovascular disease7. Evaluation of the relationship between changes in echocardiographic indices with Alb / cr before and after the use of ampoglifluosine compared with placebo in diabetic patients with stable cardiovascular disease. Timepoint: At a six-month interval after the administration of empagliflosine and placebo. Method of measurement: ELISA KIT.</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>Dr. Abidi Pharmaceutical Company</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-02</approval_date>
        <contact_name>Ethics Committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>Metabolic deases researchs center hospital  shariati Blv Zanjan Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
