<?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>IRCT20241212064032N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-01-08</date_registration>
      <primary_sponsor>Pervaiz Ilahi Institute of Cardiology, QAMC, BVH, Bahawalpur</primary_sponsor>
      <public_title>Comparison of Effectiveness between Ivabradine and Beta Blockers in Patients of Permanent Atrial Fibrillation</public_title>
      <acronym></acronym>
      <scientific_title>Comparative Efficacy of Ivabradine Versus Beta Blockers in Treatment of Uncontrolled Permanent Atrial Fibrillation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-02-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80782</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Non probability purposive sampling technique will be employed and adaptive randomization will be done according to the set criteria, Blinding description: Participants are blinded in this study as they won't know which drug group they are assigned.</study_design>
      <phase>3</phase>
      <hc_freetext>Chronic (permanent)  Atrial Fibrillation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1; This group will consist of 30 patients of permanent uncontrolled atrial fibrillation, fulfilling inclusion criteria and intolerant to beta blockers (patients having asthma, COPD, hypotension, peripheral arterial diseases, diabetics who are prone to hypoglycemia or allergic to beta blockers). After  informed consent, prospectively designed data collection Performa will be used to collect baseline information including history and demographic details. All patients will be subjected to ECG, and comprehensive clinical evaluation will be done including all baseline investigations i.e hemoglobin, serum creatinine, eGFR, transthoracic echo TTE. Systolic and diastolic BP readings and resting heart rate will be noted by duty doctor. This group will then be commenced on per oral drug IVABRADINE. A dosage of 5 milligrams per oral every 12 hours will be given for one month. Subsequently if patient tolerates this dose it can be increased to maintenance dose of 7.5 milligrams  every 12 hours. Patients who are 75 years old or more will be started on 2.5 mg 12 hourly and if tolerated well the dose can increased up to 5mg 12 hourly. Two follow up visits will be planned, one after 2 weeks and second after one month since the commencement of intervention (treatment). At each visit resting heart rate (15 minutes after sitting comfortably), systolic  and diastolic BP will be noted. History regarding syncope, palpitations, allergic reaction, treatment discontinuation or any adverse event will be noted on data collection Performa. Intervention 2: Intervention Group 2;  This group also consists of 30 patients with uncontrolled permanent atrial fibrillation. Patients will be assigned this group after excluding any contraindication to beta blockers. After informed consent, history and basic demographic details will be noted on data collection Performa. Baseline resting heart rate ,systolic and diastolic BP will be noted. All baseline investigations will be done including ECG, hemoglobin, serum creatinine, Transthoracic echo TTE and eGFR. This group will be commenced on TABLET METOPROLOL 25 milligrams  per oral 12 hourly. Subsequently the dose can be increased to therapeutic range of 25-100mg/12 hours depending upon the patient's response in following visits. Just like intervention group 1, two more follow up visits will be planned and at each visit resting heart rate, blood pressure and history regarding secondary endpoints will be noted on data collection Performa.</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 This topic is not yet discussed with the supervisor. I plan to share my data after research work is successful.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Doctor Humna Chaudri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Quaid-e-Azam Medical College, Circular road, Bahawalpur</address>
        <city>Bahawalpur</city>
        <country1>Pakistan</country1>
        <zip>63100</zip>
        <telephone>+92 62 9250411</telephone>
        <email>hamnajaved282@qamc.edu.pk</email>
        <affiliation>Pervaiz Ilahi Institute of Cardiology, QAMC, BVH, Bahawalpur</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Doctor Humna Chaudri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Quaid-e-Azam Medical College, Circular road, Bahawalpur</address>
        <city>Bahawalpur</city>
        <country1>Pakistan</country1>
        <zip>63100</zip>
        <telephone>+92 62 9250411</telephone>
        <email>hamnajaved282@qamc.edu.pk</email>
        <affiliation>Pervaiz Ilahi Institute of Cardiology, QAMC, BVH, Bahawalpur</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adult patients with ages greater than 18 years.
Fulfilling the criteria of permanent atrial fibrillation.
Resting heart rate (HR) greater than 110 beats per minute on ECG.
Capable of willingly providing informed consent.
No previous history of receiving pulmonary vein ablation.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Individuals who have a known allergy to drugs.
Conditions such as decompensated heart failure and needing inotropic drugs or intravenous diuretics within one week before enrollment in study, being in  (New York Heart Association) NYHA functional class IV, or being on the waiting list for a heart transplant.
Hypertrophic obstructive cardiomyopathy, acute pericarditis, constrictive pericarditis, acute myocarditis.
Patients with renal failure needing hemodialysis or with liver failure.
Cardiovascular or other major surgery within one month before randomization.
A severe comorbidity with a life expectancy of less than one year.
Stroke, unstable angina, or acute myocardial infarction ( within the last four weeks).
Pregnant or breastfeeding females.
Medical factors that might account  for inadequate heart rate regulation including conditions such as pheochromocytoma, fever, hyperthyroidism and anemia.
Inability to attend the planned appointments outlined in the procedure.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I48.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic atrial fibrillation</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 1; This group will consist of 30 patients of permanent uncontrolled atrial fibrillation, fulfilling inclusion criteria and intolerant to beta blockers (patients having asthma, COPD, hypotension, peripheral arterial diseases, diabetics who are prone to hypoglycemia or allergic to beta blockers). After  informed consent, prospectively designed data collection Performa will be used to collect baseline information including history and demographic details. All patients will be subjected to ECG, and comprehensive clinical evaluation will be done including all baseline investigations i.e hemoglobin, serum creatinine, eGFR, transthoracic echo TTE. Systolic and diastolic BP readings and resting heart rate will be noted by duty doctor. This group will then be commenced on per oral drug IVABRADINE. A dosage of 5 milligrams per oral every 12 hours will be given for one month. Subsequently if patient tolerates this dose it can be increased to maintenance dose of 7.5 milligrams  every 12 hours. Patients who are 75 years old or more will be started on 2.5 mg 12 hourly and if tolerated well the dose can increased up to 5mg 12 hourly. Two follow up visits will be planned, one after 2 weeks and second after one month since the commencement of intervention (treatment). At each visit resting heart rate (15 minutes after sitting comfortably), systolic  and diastolic BP will be noted. History regarding syncope, palpitations, allergic reaction, treatment discontinuation or any adverse event will be noted on data collection Performa.</i_keyword>
      <i_keyword>Intervention Group 2;  This group also consists of 30 patients with uncontrolled permanent atrial fibrillation. Patients will be assigned this group after excluding any contraindication to beta blockers. After informed consent, history and basic demographic details will be noted on data collection Performa. Baseline resting heart rate ,systolic and diastolic BP will be noted. All baseline investigations will be done including ECG, hemoglobin, serum creatinine, Transthoracic echo TTE and eGFR. This group will be commenced on TABLET METOPROLOL 25 milligrams  per oral 12 hourly. Subsequently the dose can be increased to therapeutic range of 25-100mg/12 hours depending upon the patient's response in following visits. Just like intervention group 1, two more follow up visits will be planned and at each visit resting heart rate, blood pressure and history regarding secondary endpoints will be noted on data collection Performa.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Heart Rate control. Timepoint: Before intervention then 2 weeks and 4 weeks after intervention. Method of measurement: Electrocardiography (ECG).  Heart rate will be measured by R wave method on a rhythm strip of 10 seconds ( no. of R waves in 10 seconds*6).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood Pressure. Timepoint: Before intervention, then 2 weeks and 4 weeks after intervention. Method of measurement: BP will be measured using sphygmomanometer.</sec_outcome>
      <sec_outcome>Bradycardia/Tachycardia. Timepoint: 2 weeks and 4 weeks after intervention. Method of measurement: ECG and history.</sec_outcome>
      <sec_outcome>Syncope. Timepoint: 2 weeks and 4 weeks after intervention. Method of measurement: History.</sec_outcome>
      <sec_outcome>Adverse Cardiovascular events. Timepoint: 2 weeks and 4 weeks after intervention. Method of measurement: History and medical record.</sec_outcome>
      <sec_outcome>Treatment discontinuation. Timepoint: 2 weeks and 4 weeks after intervention. Method of measurement: History.</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>Pervaiz Ilahi Institute of Cardiology, QAMC, BVH, Bahawalpur</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-04-19</approval_date>
        <contact_name>Ethical Review Committee of Quaid-e-Azam Medical College,Bahawalpur</contact_name>
        <contact_address>Quaid-e-Azam Medical College, Circular road, Bahawalpur Bahawalpur Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
