<?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>IRCT20220529055013N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-23</date_registration>
      <primary_sponsor>Public Sector medical University</primary_sponsor>
      <public_title>Dapagliflozin in Acute Heart failure</public_title>
      <acronym>AHF( Acute Heart Failure)</acronym>
      <scientific_title>Efficacy of Dapagliflozin in diabetic and nondiabetic patients with Acute heart failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64243</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants will be divided into groups as control and study groups.
the study drug( dapagliflozin) will be prescribed as add on therapy to the conventional treatment of acute heart failure in a 1:1.
simple randomization in 1:1 among  the individuals taking participation in the study, Blinding description: The study participants will be blinded.</study_design>
      <phase>4</phase>
      <hc_freetext>Heart failure with reduced ejection fraction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Tab Dapagliflozin 10 mg orally as add on therapy to the conventional treatment will be prescribed to the study participants. Intervention 2: Control group: The participants in this group will be prescribed with the conventional treatment for heart failure.</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:
title: Results. Tables and graphs of primary outcome and secondary outcome will be shared.

When:
it will be given in the duration of 10 months to 36 months after publishing. It will be available lifelong

To whom:
everyone

Conditions:
everyone who want to take advantage of this trial results will be allowed for the service of humanity.

Where to obtain:
They can talk to principal investigator of this trial Syedah Fauzia Fatima Gilani. E-mail: fauziagilani@gmail.com

How to obtain:
Email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Syedahh Fauzia Fatima Gilani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The mall, Abid Majeed road</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 51 2300714</telephone>
        <email>fauziagilani@gmail.com</email>
        <affiliation>National University of medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Syedah Fauzia Fatima GIlani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>the mall, Abid Majeed road</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>0092 51</telephone>
        <email>fauziagilani@gmail.com</email>
        <affiliation>Public Sector Medical College</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. Male/Female patients 30 years and above
2. Diagnosis of acute decompensated heart failure made on admission based on any two of the following signs and symptoms a)Dyspnea at rest or minimal exertion b)Peripheral edema c) Ascites d)5-pound weight gain (rapid)  e) Signs of congestion on X-ray
3. Left ventricular Ejection fraction ≤ 40%
4. eGFR ≥ 30ml/min</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Cardiogenic shock;
urgent hospitalization for acute heart failure primarily triggered by pulmonary embolism ,cerebrovascular accident, or acute myocardial infarction
Current hospitalization for acute heart failure not caused primarily by intravascular volume overload
Type 1 Diabetes mellitus
History of Diabetic ketoacidosis
History of hepatic impairment
Known allergy to SGLT 2 inhibitors
Women pregnant or breast feeding</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Tab Dapagliflozin 10 mg orally as add on therapy to the conventional treatment will be prescribed to the study participants</i_keyword>
      <i_keyword>Control group: The participants in this group will be prescribed with the conventional treatment for heart failure</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Improvement in symptoms and quality of life of heart failure patients admitted with acute decompensation. Timepoint: At admission( baseline), followed at  Day 1,day7 and day 30. Method of measurement: Kansas city cardiomyopathy questionnaire (KCCQ).</prim_outcome>
      <prim_outcome>Effect of drug on kidney function. Timepoint: At day 0, 1, 7 and 30. Method of measurement: estimated glomerular filtration rate ( eGFR).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Improvement in Hemoglobin levels. Timepoint: Day 0, 1, 7 and day 30. Method of measurement: complete blood count.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: Day 0,1 7 and 30. Method of measurement: Sphygmamometer.</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>Public Sector medical University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-31</approval_date>
        <contact_name>Ethics review committee of public sector hospital</contact_name>
        <contact_address>the mall, abid majeed road Rawalpindi Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
