<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/NCT04415203</url>
  </required_header>
  <id_info>
    <org_study_id>TAESforFPVC</org_study_id>
    <nct_id>NCT04415203</nct_id>
  </id_info>
  <brief_title>TAES for FPVCs: a Pragmatic, Randomized Controlled Trial</brief_title>
  <official_title>Transcutaneous Acupoint Electrical Stimulation for Frequent Premature Ventricular Contractions: a Pragmatic, Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>China Association for Science and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective, pragmatic, randomized controlled trial aims to evaluate the efficacy and&#xD;
      safety of transcutaneous acupoint electrical stimulation (TAES) for patients with frequent&#xD;
      premature ventricular contractions (FPVCs). Ninety participants will be randomized to TAES&#xD;
      group and sham-TAES group with the ratio of 1:1. They will receive TAES plus usual care or&#xD;
      sham-TAES plus usual care for 6 weeks, and then be followed up for 12 weeks after the&#xD;
      treatment. The primary outcome was the proportion of participants with a 50% decrease of the&#xD;
      24 hour (24h) premature ventricular contractions (PVCs) after 6-week treatment. Secondary&#xD;
      outcomes include the proportion of participants with a 75% decrease of the 24h-PVCs; the&#xD;
      decrease from baseline of 24h-PVCs, total 24h-heartbeat, and the frequency of&#xD;
      supraventricular arrhythmia; the score change from baseline in PVCs-related symptoms; the&#xD;
      score change from baseline in SAS and SDS. Subgroup analyses will be performed in age,&#xD;
      gender, and the severity of PVCs. Safety assessment will be documented during the whole&#xD;
      trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 4, 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <phase>N/A</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, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the proportion of participants with a 50% decrease of PVCs from baseline</measure>
    <time_frame>week 6</time_frame>
    <description>The PVCs will be assessed by a 24-hour Holter monitoring. The investigators will calculate the decrease of PVCs between baseline and week 6 (at the end of the treatment), then we will obtain the proportion of patients with a 50% decrease.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the proportion of participants with a 50% decrease of PVCs from baseline</measure>
    <time_frame>week 18</time_frame>
    <description>The PVCs will be assessed by a 24-hour Holter monitoring. The investigators will calculate the decrease of PVCs between baseline and week 18 (at the end of the follow-up period), then we will obtain the proportion of patients with a 50% decrease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the proportion of participants with a 75% decrease of PVCs from baseline</measure>
    <time_frame>week 6, week 18</time_frame>
    <description>The PVCs will be assessed by a 24-hour Holter monitoring. The investigators will calculate the decrease of PVCs between baseline and week 6/18, then we will obtain the proportion of patients with a 75% decrease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the change from baseline in PVCs</measure>
    <time_frame>week 6, week 18</time_frame>
    <description>The PVCs will be assessed by a 24-hour Holter monitoring. The investigators will calculate the decrease of PVCs between baseline and week 6/18.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the change from baseline in total cardiac impulse</measure>
    <time_frame>week 6, week 18</time_frame>
    <description>The total cardiac impulse will be assessed by a 24-hour Holter monitoring. The investigators will calculate the change of total cardiac impulse between baseline and week 6/18.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the change from baseline in supraventricular premature contractions</measure>
    <time_frame>week 6, week 18</time_frame>
    <description>The change from baseline in supraventricular premature contractions will be assessed by a 24-hour Holter monitoring. The investigators will calculate the change of supraventricular premature contractions between baseline and week 6/18.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the score change from baseline in the symptom of palpitation</measure>
    <time_frame>week 6, week 18.</time_frame>
    <description>The symptom of palpitation will be assessed by a 10-scale VAS from 0 to 10, a higher score indicates a more severe symptom of palpitation. The investigators will calculate the score change of palpitation between baseline and week 6/18.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the score change from baseline in the symptom of chest tightness</measure>
    <time_frame>week 6, week 18.</time_frame>
    <description>The symptom of chest tightness will be assessed by a 10-scale VAS from 0 to 10, a higher score indicates a more severe symptom of chest tightness. The investigators will calculate the score change of chest tightness between baseline and week 6/18.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the score change from baseline in the symptom of dizziness</measure>
    <time_frame>week 6, week 18.</time_frame>
    <description>The symptom of dizziness will be assessed by a 10-scale VAS from 0 to 10, a higher score indicates a more severe symptom of dizziness. The investigators will calculate the score change of dizziness between baseline and week 6/18.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the score change from baseline in the symptom of insomnia</measure>
    <time_frame>week 6, week 18.</time_frame>
    <description>The symptom of insomnia will be assessed by a 10-scale VAS from 0 to 10, a higher score indicates a more severe symptom of insomnia. The investigators will calculate the score change of insomnia between baseline and week 6/18.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the change of the proportion of participants with moderate/severe symptoms of palpitation, chest tightness, dizziness or insomnia from baseline</measure>
    <time_frame>week 6, week 18.</time_frame>
    <description>The symptom of palpitation/chest tightness/dizziness/insomnia will be assessed by a 10-scale VAS from 0 to 10. Score 4-6 are defined as the moderate level, Score 7-10 are defined as the severe level. The investigators will calculate the change of the proportion of patients with the moderate/severe symptoms between baseline and week 6/18.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the score change from baseline in the SAS</measure>
    <time_frame>week 6, week 18.</time_frame>
    <description>Self Anxiety Scale (SAS) contains 20 items scored from 25 to 100. Score 50-59 was classified as mild anxiety; Score 60-69 as moderate anxiety, and score ≥ 70 as severe anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the score change from baseline in the SDS</measure>
    <time_frame>week 6, week 18.</time_frame>
    <description>Self Depression Scale (SDS) contains 20 items scored from 25 to 100. Score 53-62 was classified as mild depression; Score 63-72 as moderate depression, and score ≥ 73 as severe depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the score change from baseline in SF-36</measure>
    <time_frame>week 6, week 18.</time_frame>
    <description>The SF-36 questionnaire contains eight scales with two measures: physical and mental health. The physical health includes four scales of physical functioning (PF), role-physical (RF), bodily pain (BP), and general health (GH). The mental health is composed of vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH).&#xD;
SF-36 scores from 0 to 100, higher scores indicate better health status.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>subgroup analysis of ages</measure>
    <time_frame>week 6</time_frame>
    <description>Subgroup analysis will be performed in the primary outcome. The investigators will classify the patients with two subgroups by age: ≤40 years and &gt; 40 years.</description>
  </other_outcome>
  <other_outcome>
    <measure>subgroup analysis of gender</measure>
    <time_frame>week 6</time_frame>
    <description>Subgroup analysis will be performed in the primary outcome. The investigators will classify the patients with two subgroups by gender: male and female.</description>
  </other_outcome>
  <other_outcome>
    <measure>subgroup analysis of the severity of PVCs</measure>
    <time_frame>week 6</time_frame>
    <description>Subgroup analysis will be performed in the primary outcome. The investigators will classify the patients with three subgroups by the severity of PVCs through Lown: level 2, level 3, and level 4A</description>
  </other_outcome>
  <other_outcome>
    <measure>the proportion of participants with adverse events</measure>
    <time_frame>week 6, week 18</time_frame>
    <description>Safety assessment, The investigators will calculate the adverse events during the whole study.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Premature Ventricular Contraction</condition>
  <arm_group>
    <arm_group_label>TAES plus usual care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAES on Neiguan (PC6), Shenmen (HT7), Erzhong and Xin (Auricular Acupuncture Point); Usual Care: usual medicine treatment for PVCs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham-TAES plus usual care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sham-TAES on Neiguan (PC6), Shenmen (HT7), Erzhong and Xin (Auricular Acupuncture Point); the same acupoints as the treatment group without any current.&#xD;
Usual Care: usual medicine treatment for PVCs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcutaneous acupoint electrical stimulation (TAES)</intervention_name>
    <description>Patients in TAES group will receive TAES and usual care. TAES will be performed on Neiguan (PC6), Shenmen (HT7), Erzhong and Xin (Auricular Acupuncture Point) for 6 weeks by using the Huato type SDZ-V stimulator; Usual Care: usual medicine treatment for PVCs.</description>
    <arm_group_label>TAES plus usual care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham Transcutaneous acupoint electrical stimulation (Sham-TAES)</intervention_name>
    <description>Patients in sham-TAES group will receive sham-TAES and usual care. Sham-TAES will be also performed on Neiguan (PC6), Shenmen (HT7), Erzhong and Xin (Auricular Acupuncture Point) for 6 weeks by using a special Huato type SDZ-V stimulator. We cut the inner electric wire of the stimulator; therefore, there is no current output. Usual Care: usual medicine treatment for PVCs.</description>
    <arm_group_label>Sham-TAES plus usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed as frequent premature ventricular contractions;&#xD;
&#xD;
          -  2 ≤ Lown level ≤ 4A;&#xD;
&#xD;
          -  18 ≤ age ≤ 75;&#xD;
&#xD;
          -  Volunteered to participant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe valvular disease, congenital heart disease, pericardial disease, hypertrophic&#xD;
             cardiomyopathy, unstable angina pectoris, acute myocardial infarction, myocarditis,&#xD;
             aneurysm, congestive heart failure decompensation period (NYHA grade III or VI),&#xD;
             cardiogenic shock, cerebrovascular disease, hematopoietic system disease, severe&#xD;
             mental disease;&#xD;
&#xD;
          -  Bradycardia, including pathologic sinus node syndrome, degree II or greater&#xD;
             atrioventricular block;&#xD;
&#xD;
          -  Those who have already had pacemaker or percutaneous coronary intervention, or who&#xD;
             plan to have pacemaker or percutaneous coronary intervention;&#xD;
&#xD;
          -  Pregnant or lactating women;&#xD;
&#xD;
          -  Local sensory deficit, or allergic to current;&#xD;
&#xD;
          -  May be allergic to percutaneous patches；&#xD;
&#xD;
          -  Blood pressure ≤ 90/60 mmHg;&#xD;
&#xD;
          -  Those who have participated in other clinical trials within 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiani Wu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jiani Wu</last_name>
    <phone>+8613426116653</phone>
    <email>handsom_mars@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Guang'anmen Hospita, China Academy of Chinese Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiani Wu</last_name>
      <phone>+8613426116653</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>May 30, 2020</study_first_submitted>
  <study_first_submitted_qc>May 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>August 4, 2021</last_update_submitted>
  <last_update_submitted_qc>August 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</investigator_affiliation>
    <investigator_full_name>Jiani Wu</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Ventricular Premature Complexes</mesh_term>
  </condition_browse>
  <!-- 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/NCT04415203
org study id: TAESforFPVC
nct id: NCT04415203
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This prospective, pragmatic, randomized controlled trial aims to evaluate the efficacy and
      safety of transcutaneous acupoint electrical stimulation (TAES) for patients with frequent
      premature ventricular contractions (FPVCs). Ninety participants will be randomized to TAES
      group and sham-TAES group with the ratio of 1:1. They will receive TAES plus usual care or
      sham-TAES plus usual care for 6 weeks, and then be followed up for 12 weeks after the
      treatment. The primary outcome was the proportion of participants with a 50% decrease of the
      24 hour (24h) premature ventricular contractions (PVCs) after 6-week treatment. Secondary
      outcomes include the proportion of participants with a 75% decrease of the 24h-PVCs; the
      decrease from baseline of 24h-PVCs, total 24h-heartbeat, and the frequency of
      supraventricular arrhythmia; the score change from baseline in PVCs-related symptoms; the
      score change from baseline in SAS and SDS. Subgroup analyses will be performed in age,
      gender, and the severity of PVCs. Safety assessment will be documented during the whole
      trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: the proportion of participants with a 50% decrease of PVCs from baseline
time frame: week 6
description: The PVCs will be assessed by a 24-hour Holter monitoring. The investigators will calculate the decrease of PVCs between baseline and week 6 (at the end of the treatment), then we will obtain the proportion of patients with a 50% decrease.
measure: the proportion of participants with a 50% decrease of PVCs from baseline
time frame: week 18
description: The PVCs will be assessed by a 24-hour Holter monitoring. The investigators will calculate the decrease of PVCs between baseline and week 18 (at the end of the follow-up period), then we will obtain the proportion of patients with a 50% decrease.
measure: the proportion of participants with a 75% decrease of PVCs from baseline
time frame: week 6, week 18
description: The PVCs will be assessed by a 24-hour Holter monitoring. The investigators will calculate the decrease of PVCs between baseline and week 6/18, then we will obtain the proportion of patients with a 75% decrease.
measure: the change from baseline in PVCs
time frame: week 6, week 18
description: The PVCs will be assessed by a 24-hour Holter monitoring. The investigators will calculate the decrease of PVCs between baseline and week 6/18.
measure: the change from baseline in total cardiac impulse
time frame: week 6, week 18
description: The total cardiac impulse will be assessed by a 24-hour Holter monitoring. The investigators will calculate the change of total cardiac impulse between baseline and week 6/18.
measure: the change from baseline in supraventricular premature contractions
time frame: week 6, week 18
description: The change from baseline in supraventricular premature contractions will be assessed by a 24-hour Holter monitoring. The investigators will calculate the change of supraventricular premature contractions between baseline and week 6/18.
measure: the score change from baseline in the symptom of palpitation
time frame: week 6, week 18.
description: The symptom of palpitation will be assessed by a 10-scale VAS from 0 to 10, a higher score indicates a more severe symptom of palpitation. The investigators will calculate the score change of palpitation between baseline and week 6/18.
measure: the score change from baseline in the symptom of chest tightness
time frame: week 6, week 18.
description: The symptom of chest tightness will be assessed by a 10-scale VAS from 0 to 10, a higher score indicates a more severe symptom of chest tightness. The investigators will calculate the score change of chest tightness between baseline and week 6/18.
measure: the score change from baseline in the symptom of dizziness
time frame: week 6, week 18.
description: The symptom of dizziness will be assessed by a 10-scale VAS from 0 to 10, a higher score indicates a more severe symptom of dizziness. The investigators will calculate the score change of dizziness between baseline and week 6/18.
measure: the score change from baseline in the symptom of insomnia
time frame: week 6, week 18.
description: The symptom of insomnia will be assessed by a 10-scale VAS from 0 to 10, a higher score indicates a more severe symptom of insomnia. The investigators will calculate the score change of insomnia between baseline and week 6/18.
measure: the change of the proportion of participants with moderate/severe symptoms of palpitation, chest tightness, dizziness or insomnia from baseline
time frame: week 6, week 18.
description: The symptom of palpitation/chest tightness/dizziness/insomnia will be assessed by a 10-scale VAS from 0 to 10. Score 4-6 are defined as the moderate level, Score 7-10 are defined as the severe level. The investigators will calculate the change of the proportion of patients with the moderate/severe symptoms between baseline and week 6/18.
measure: the score change from baseline in the SAS
time frame: week 6, week 18.
description: Self Anxiety Scale (SAS) contains 20 items scored from 25 to 100. Score 50-59 was classified as mild anxiety; Score 60-69 as moderate anxiety, and score ≥ 70 as severe anxiety.
measure: the score change from baseline in the SDS
time frame: week 6, week 18.
description: Self Depression Scale (SDS) contains 20 items scored from 25 to 100. Score 53-62 was classified as mild depression; Score 63-72 as moderate depression, and score ≥ 73 as severe depression.
measure: the score change from baseline in SF-36
time frame: week 6, week 18.
description: The SF-36 questionnaire contains eight scales with two measures: physical and mental health. The physical health includes four scales of physical functioning (PF), role-physical (RF), bodily pain (BP), and general health (GH). The mental health is composed of vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH).
SF-36 scores from 0 to 100, higher scores indicate better health status.
measure: subgroup analysis of ages
time frame: week 6
description: Subgroup analysis will be performed in the primary outcome. The investigators will classify the patients with two subgroups by age: ≤40 years and > 40 years.
measure: subgroup analysis of gender
time frame: week 6
description: Subgroup analysis will be performed in the primary outcome. The investigators will classify the patients with two subgroups by gender: male and female.
measure: subgroup analysis of the severity of PVCs
time frame: week 6
description: Subgroup analysis will be performed in the primary outcome. The investigators will classify the patients with three subgroups by the severity of PVCs through Lown: level 2, level 3, and level 4A
measure: the proportion of participants with adverse events
time frame: week 6, week 18
description: Safety assessment, The investigators will calculate the adverse events during the whole study.
arm group label: TAES plus usual care
arm group type: Experimental
description: TAES on Neiguan (PC6), Shenmen (HT7), Erzhong and Xin (Auricular Acupuncture Point); Usual Care: usual medicine treatment for PVCs.
arm group label: Sham-TAES plus usual care
arm group type: Placebo Comparator
description: Sham-TAES on Neiguan (PC6), Shenmen (HT7), Erzhong and Xin (Auricular Acupuncture Point); the same acupoints as the treatment group without any current.
Usual Care: usual medicine treatment for PVCs.
intervention type: Device
intervention name: Transcutaneous acupoint electrical stimulation (TAES)
description: Patients in TAES group will receive TAES and usual care. TAES will be performed on Neiguan (PC6), Shenmen (HT7), Erzhong and Xin (Auricular Acupuncture Point) for 6 weeks by using the Huato type SDZ-V stimulator; Usual Care: usual medicine treatment for PVCs.
arm group label: TAES plus usual care
intervention type: Device
intervention name: Sham Transcutaneous acupoint electrical stimulation (Sham-TAES)
description: Patients in sham-TAES group will receive sham-TAES and usual care. Sham-TAES will be also performed on Neiguan (PC6), Shenmen (HT7), Erzhong and Xin (Auricular Acupuncture Point) for 6 weeks by using a special Huato type SDZ-V stimulator. We cut the inner electric wire of the stimulator; therefore, there is no current output. Usual Care: usual medicine treatment for PVCs.
arm group label: Sham-TAES plus usual care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jiani Wu
role: Principal Investigator
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
last name: Jiani Wu
phone: +8613426116653
email: handsom_mars@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
investigator full name: Jiani Wu
investigator title: Dr
mesh term: Premature Birth
mesh term: Ventricular Premature Complexes