<?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>IRCT20220809055644N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-12</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>"Efficacy of diuretic therapy with furosemide compared with combined diuretic therapy with furosemide and indapamide in treatment of congestive heart failure"</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the efficacy of diuretic therapy with furosemide compared with combined diuretic therapy with furosemide and indapamide in treatment of patients with  congestive heart failure: A randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>180</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65180</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The website http://www.randomization.com/ will be used for randomization. The randomization of this study will be by the blocked randomization method. Based on the list of codes obtained from this website, each patient will be randomly assigned to the intervention or control group using blocks of 4 in a ratio of 1:1. For concealment, a code will be assigned to each patient and each of the randomly generated codes will be written on a card. Then they will be placed inside sealed opaque envelopes in random order. In order to maintain the random sequence, the outer surface of the envelopes will be numbered in the same order. Finally, the lid of the letter envelopes will be glued and will be placed in a box respectively. At the time of sampling, one of the envelopes will be determined according to the opening order and the assigned group of that participant, Blinding description: For the purpose of blinding, placebos completely identical in terms of color, smell, shape and size to indapamide drug will be prepared for this study. The indapamide drug used for the patients of this plan will also be provided to the patients without any label (only if it is obvious to the person giving the medicine) in unlabeled cans and by the prescribing doctor. In this study, participants and Assessors are blind.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Congestive heart failure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: It will include 90 patients with congestive heart failure. In addition to the daily consumption of furosemide 20 mg three times a day, one pill each time, the intervention group will also take the diuretic indapamide 1.5 mg once a day. This group will take furosemide and indapamide diuretics for three months. Intervention 2: Control group: Control group: Including 90 patients with congestive heart failure. For the participants in the control group, the diuretic furosemide will be prescribed along with placebo. In this way, the patients of this group will take furosemide 20 mg three times a day, one tablet each time, and placebo one tablet a day. This group will take furosemide and placebo for three months.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is "No more information"</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amir Aris</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Cardiovascular Diseases Research Center, Dr. Heshmat Heart Hospital, 15th of  Khordad Street, Mosalla Square, Guilan, Rasht, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4193955588</zip>
        <telephone>009833618177</telephone>
        <email>aris_amir@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir Aris</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Cardiovascular Diseases Research Center, Dr. Heshmat Heart Hospital, 15th of  Khordad Street, Mosalla Square, Guilan, Rasht, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4193955588</zip>
        <telephone>+98 13 3361 8177</telephone>
        <email>aris_amir@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>"Suffering from congestive heart failure"
" NYHA class of all participants is 2,3, or 4"
" Willingness to participate in the study"</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>"Severe hypokalemia"
"Glomerular filtration rate (GFR) less than 15 ml/min"
"Suffering from chronic obstructive pulmonary disease(COPD)"
"LVEF  more than 40 %"
"Diastolic dysfunction grade Ⅱ  and above"
"Uric acid above 10 mg/dL"</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>150.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Congestive heart disease</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: It will include 90 patients with congestive heart failure. In addition to the daily consumption of furosemide 20 mg three times a day, one pill each time, the intervention group will also take the diuretic indapamide 1.5 mg once a day. This group will take furosemide and indapamide diuretics for three months.</i_keyword>
      <i_keyword>Control group: Control group: Including 90 patients with congestive heart failure. For the participants in the control group, the diuretic furosemide will be prescribed along with placebo. In this way, the patients of this group will take furosemide 20 mg three times a day, one tablet each time, and placebo one tablet a day. This group will take furosemide and placebo for three months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Assessment symptoms of congestion. Timepoint: At the beginning of the study (before the start of the intervention), one month and three months after the start of taking the studied diuretics. Method of measurement: Physical examination of the patient in terms of congestion.</prim_outcome>
      <prim_outcome>Evaluation of electrolyte disorders. Timepoint: Before the intervention, 1 month and 3 months after the intervention. Method of measurement: Blood tests.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-06</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Cardiovascular Diseases Research Center, Dr. Heshmat Heart Hospital, 15th of  Khordad Street, Mosalla Square, Guilan, Rasht, Iran Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
