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Acupuncture in Persistent Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT02110537
Recruitment Status : Unknown
Verified April 2014 by Weon Kim, Kyunghee University Medical Center.
Recruitment status was:  Recruiting
First Posted : April 10, 2014
Last Update Posted : April 10, 2014
Sponsor:
Collaborator:
Ministry of Health & Welfare, Korea
Information provided by (Responsible Party):
Weon Kim, Kyunghee University Medical Center

Brief Summary:
The aim of this trial is to evaluate the effect of acupuncture on prevention of atrial fibrillation (AF) recurrence after electrical cardioversion (EC) for persistent AF patients resistant to the antiarrhythmic drugs (AADs).

Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Procedure: Active Acupuncture Procedure: Sham acupuncture Drug: flecainide Not Applicable

Detailed Description:

This is a multicenter, prospective, participant and assessor blinded, randomized, sham-controlled clinical trial with 2 parallel arms. To evaluate the efficacy and safety of acupuncture, a total of 80 persistent AF participants will be recruited and randomly assigned to active acupuncture and sham acupuncture group. Both group commonly take antiarrhythmic medication during study period. These patients who are resistant to drug therapy will get a electrical cardioversion. After cardioversion, the recurrence rate and duration of atrial fibrillation free time will be evaluated.

This trial consists of 2 weeks of observation and medical therapy, 2 weeks of acupuncture intervention before EC, EC and acupuncture intervention, 7 weeks of additional intervention, and 5 weeks of follow-up. After randomization, participants receive 10 sessions of acupuncture treatments over 10 weeks. The outcome is assessed at 2, 4, 6, 8, and 16 week after randomization.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial to Evaluate the Antiarrhythmic Effects of Acupuncture for Drug Resistant Persistent Atrial Fibrillation: Randomized, Participant and Assessor Blinded, Sham-controlled, Clinical Trial
Study Start Date : March 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active Acupuncture + flecainide
The participants in this group receive verum acupuncture treatment once a week for 10 weeks and flecainide 75 mg twice daily.
Procedure: Active Acupuncture
Active acupuncture treatment group consists of electroacupuncture (EA) and intradermal acupuncture (IDA). For EA treatment, unilateral PC5, PC6, ST36, and ST37 are chosen. Disposable, sterile needles and low frequency electrical stimulator (ES-160, ITO, Japan) are used. Each needle is inserted to the depth of 2 ± 0.5 cm with a 90 degree angle. Thereafter, needles are connected with the pole and electrical stimulation is applied with 2Hz, continuous wave current for 20 minutes. For IDA treatment, bilateral HT7 and TF4 are selected. Disposable, sterile, sticker-type needles (0.18 mm x 1.3 mm x 1.5mm) are used. Attached needles are maintained as long as possible.

Drug: flecainide
Both groups commonly take antiarrhythmic medication (flecainide 75 mg twice daily) during study period. Flecainide administration is initiated 2 weeks before electrical cardioversion and maintain during follow up period.
Other Name: tambocor

Sham Comparator: Sham acupuncture + flecainide
The participants in this group receive sham acupuncture treatment once a week for 10 weeks and flecainide 75 mg twice daily.
Procedure: Sham acupuncture
For sham intervention, nonacupuncture points are used. As with active treatment group, two types of acupuncture, sham EA and sham IDA, compose the sham intervention. Electrical acupuncture is connected but electrical stimulation is not given to sham acupuncture group.

Drug: flecainide
Both groups commonly take antiarrhythmic medication (flecainide 75 mg twice daily) during study period. Flecainide administration is initiated 2 weeks before electrical cardioversion and maintain during follow up period.
Other Name: tambocor




Primary Outcome Measures :
  1. Recurrence of atrial fibrillation evaluated on serial electrocardiography and 48 hour holter monitoring after sinus conversion by electrical cardioversion [ Time Frame: 3 months after electrical cardioversion ]
    When patient feel symptoms such as palpitation and chest discomfort, the patients are recommended to visit hospital to check out the recurrence of atrial fibrillation.


Secondary Outcome Measures :
  1. Changes in function and volume of left atrium and left atrial appendage evaluated by echocardiography [ Time Frame: 3 months after electrical cardioversion ]
  2. Change of inflammation marker (hsCRP) [ Time Frame: 3 months after electrical cardioversion ]
    Other markers can be added

  3. Number of Participants with Adverse Events (AEs) [ Time Frame: Participants will be followed for the duration of this study, an expected average 14 weeks ]
    All participants and practitioners are taught to report any AEs. If there are any AEs, the following items are recorded by practitioners at each visit and appropriate actions are taken: type of AEs, occurrence date, lost date, frequency of occurrence, severity, causality with the treatment, actions taken with the acupuncture intervention, and actions taken to the participants. Serious AEs, i.e. death or life-threatening events which are required urgent intervention, will be noted to the principal investigators immediately and determine whether the participants are dropped out.

  4. the factor to make atrial fibrillation recur [ Time Frame: 3 months later after electrical cardioversion ]
    we will perform multivariate regression analysis to know which factor makes atrial fibrillation recur irrespective of intervention method.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Persistent AF lasting ≥ 7 days
  • Ages in 20-75 years
  • Resistant with antiarrhythmic drugs
  • Written informed consent

Exclusion Criteria:

  • Age below 20 years or above 75 years
  • Severe valvular heart disease
  • History of open heart surgery
  • History of treatment for myocardial infarction (MI) within recent 6 weeks
  • Patients under or requiring the administration of antiviral drugs
  • 2nd degree atrioventricular block or more than two fascicular block
  • Severe pulmonary, liver, or renal disease
  • Previous acupuncture treatment for cardiovascular condition within 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02110537


Contacts
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Contact: Weon Kim, Professor 82-2-958-8176 mylovekw@hanmail.net

Locations
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Korea, Republic of
Kyung Hee University Medical Center Recruiting
Seoul, Dongdaemun-gu, Korea, Republic of, 130-701
Contact: Weon Kim, Professor    82-2-958-8176    mylovekw@hanmail.net   
Principal Investigator: Weon Kim, Professor         
Sponsors and Collaborators
Kyunghee University Medical Center
Ministry of Health & Welfare, Korea
Investigators
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Principal Investigator: Weon Kim, Professor Kyunghee University Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Weon Kim, Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT02110537    
Other Study ID Numbers: HI13C0580
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: April 10, 2014
Last Verified: April 2014
Keywords provided by Weon Kim, Kyunghee University Medical Center:
Atrial fibrillation
Acupuncture
Recurrence
Electrical cardioversion
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Flecainide
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action