<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03273634</url>
  </required_header>
  <id_info>
    <org_study_id>123</org_study_id>
    <nct_id>NCT03273634</nct_id>
  </id_info>
  <brief_title>The Effect of Proton Pump Inhibition on Palpitations</brief_title>
  <official_title>The Effect of Proton Pump Inhibition on Palpitations With no Apparent Cause. A Double Blinded Randomized Placebo Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jordan Collaborating Cardiology Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Jordan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jordan Collaborating Cardiology Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Feeling of palpitations with no clear arrhythmia is frequently encountered in clinical&#xD;
      practice. The majority of these patients have documented sinus rhythm even while having&#xD;
      symptoms. Gastrointestinal association with such symptoms was first described by Ludwig von&#xD;
      Roemheld (1871-1938).The investigators thought to investigate the effect of proton pump&#xD;
      inhibition in patients with feeling of palpitations but no clear cause.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One hundred and fifty patients with palpitations and no clear cause for their symptoms will&#xD;
      be randomized to receive either proton pump inhibitor (PPI) (lanzoprazole 30 mg) or placebo&#xD;
      for one month. At base line they will be investigated to rule out arrhythmia by documenting&#xD;
      normal heart rate (less than 110 beat per minute) or ECG showing normal sinus rhythm or mild&#xD;
      sinus tachycardia (Less than 110 per minute) during symptoms. Obvious causes such as anxiety&#xD;
      due to a stressful event or organic causes such anemia or thyroid disorders should be also&#xD;
      ruled out.&#xD;
&#xD;
      Patient who agree to participate in the study will be asked to sign an informed consent. A&#xD;
      baseline questionnaire with symptoms will be filled. They will then be randomized for&#xD;
      treatment with either PPI or placebo once at night time. After 10 days of treatment they will&#xD;
      be contacted and questioned regarding their symptoms. The two groups will be compared to see&#xD;
      if there is any improvement of symptoms with treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2017</start_date>
  <completion_date type="Actual">June 1, 2018</completion_date>
  <primary_completion_date type="Actual">May 1, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>Similarly looking tablets and placebo with care providers not knowing which is which. Packets are marked &quot;heads and tails&quot; for randomization</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in symptoms</measure>
    <time_frame>10 days after starting treatment</time_frame>
    <description>Assessment of improvement in palpitations using a questionnaire. The improvement will be graded either non, mild, moderate, or great. The result will either negative (no or mild improvement), or positive (moderate or great improvement)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Arrhythmia</condition>
  <arm_group>
    <arm_group_label>Active treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The treatment will consist of lanzoprazole 30 mg once daily at night time</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A Placebo pill to be given with similar looking to experimental drug but contains inactive ingredient</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lansoprazole Pill</intervention_name>
    <description>once daily at night time</description>
    <arm_group_label>Active treatment</arm_group_label>
    <other_name>Lanzotec</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Persons with palpitations and no clear cause who are above the age of 16 years and who&#xD;
             consent to the study will be included&#xD;
&#xD;
          2. Clear causes that should be excluded are true arrhythmia such SVT or VT or frequent&#xD;
             premature atrial or ventricular contractions or any organic cause such as thyroid&#xD;
             disorder, anemia (hg less than 11 g/dl) and obvious anxiety disorder&#xD;
&#xD;
          3. Arrhythmia can be excluded by an ECG showing sinus rhythm or sinus tachycardia during&#xD;
             episodes or measurement of heart rate by a reliable method during symptoms showing&#xD;
             regular heart rate less than 120 beats per minute.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Refusal to sign consent form&#xD;
&#xD;
          2. Already taking PPI or H2 blocker&#xD;
&#xD;
          3. Frequency of symptoms less than 2 times per week&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Omar Ubaidat, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Jordan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Jordan</name>
      <address>
        <city>Amman</city>
        <zip>11942</zip>
        <country>Jordan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Jordan</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>August 7, 2018</last_update_submitted>
  <last_update_submitted_qc>August 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Palpitations</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lansoprazole</mesh_term>
    <mesh_term>Dexlansoprazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03273634
org study id: 123
nct id: NCT03273634
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Feeling of palpitations with no clear arrhythmia is frequently encountered in clinical
      practice. The majority of these patients have documented sinus rhythm even while having
      symptoms. Gastrointestinal association with such symptoms was first described by Ludwig von
      Roemheld (1871-1938).The investigators thought to investigate the effect of proton pump
      inhibition in patients with feeling of palpitations but no clear cause.
One hundred and fifty patients with palpitations and no clear cause for their symptoms will
      be randomized to receive either proton pump inhibitor (PPI) (lanzoprazole 30 mg) or placebo
      for one month. At base line they will be investigated to rule out arrhythmia by documenting
      normal heart rate (less than 110 beat per minute) or ECG showing normal sinus rhythm or mild
      sinus tachycardia (Less than 110 per minute) during symptoms. Obvious causes such as anxiety
      due to a stressful event or organic causes such anemia or thyroid disorders should be also
      ruled out.

      Patient who agree to participate in the study will be asked to sign an informed consent. A
      baseline questionnaire with symptoms will be filled. They will then be randomized for
      treatment with either PPI or placebo once at night time. After 10 days of treatment they will
      be contacted and questioned regarding their symptoms. The two groups will be compared to see
      if there is any improvement of symptoms with treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
masking description: Similarly looking tablets and placebo with care providers not knowing which is which. Packets are marked "heads and tails" for randomization
measure: Improvement in symptoms
time frame: 10 days after starting treatment
description: Assessment of improvement in palpitations using a questionnaire. The improvement will be graded either non, mild, moderate, or great. The result will either negative (no or mild improvement), or positive (moderate or great improvement)
arm group label: Active treatment
arm group type: Experimental
description: The treatment will consist of lanzoprazole 30 mg once daily at night time
arm group label: Placebo
arm group type: Placebo Comparator
description: A Placebo pill to be given with similar looking to experimental drug but contains inactive ingredient
intervention type: Drug
intervention name: Lansoprazole Pill
description: once daily at night time
arm group label: Active treatment
other name: Lanzotec
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 16 Years
maximum age: 99 Years
healthy volunteers: No
last name: Omar Ubaidat, MD
role: Study Chair
affiliation: Jordan University Hospital
facility: 
country: Jordan
responsible party type: Sponsor
mesh term: Arrhythmias, Cardiac
mesh term: Lansoprazole
mesh term: Dexlansoprazole
sharing ipd: No