Persistent Atrial FibrillationNCT02110537
Acupuncture in Persistent Atrial Fibrillation
A study testing Active Acupuncture and flecainide in people with Persistent Atrial Fibrillation, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Active Acupuncture and flecainide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent AF lasting ≥ 7 days
- Ages in 20-75 years
- Resistant with antiarrhythmic drugs
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyung Hee University Medical Center
Seoul, Dongdaemun-gu, 130-701
Weon Kim, Professor, 82-2-958-8176, mylovekw@hanmail.net
Weon Kim, Professor
About this study
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
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).
Read the 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.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Active Acupuncture, Sham acupuncture, flecainide
- Keywords
- Atrial fibrillation, Acupuncture, Recurrence, Electrical cardioversion
- Medical subject headings
- Atrial Fibrillation, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active AcupunctureProcedure or surgery
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.
Sham acupunctureProcedure or surgery
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.
flecainideDrug
Also called tambocor
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Acupuncture + flecainide | Experimental | The participants in this group receive verum acupuncture treatment once a week for 10 weeks and flecainide 75 mg twice daily. Receives: Procedure: Active Acupuncture; Drug: flecainide |
| Sham acupuncture + flecainide | Sham comparator | The participants in this group receive sham acupuncture treatment once a week for 10 weeks and flecainide 75 mg twice daily. Receives: Procedure: Sham acupuncture; Drug: flecainide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of atrial fibrillation evaluated on serial electrocardiography and 48 hour holter monitoring after sinus conversion by 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.
Measured: 3 months after electrical cardioversion
Secondary outcomes (4)
Changes in function and volume of left atrium and left atrial appendage evaluated by echocardiography
Measured: 3 months after electrical cardioversion
Change of inflammation marker (hsCRP)
Other markers can be added
Measured: 3 months after electrical cardioversion
Number of Participants with Adverse Events (AEs)
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.
Measured: Participants will be followed for the duration of this study, an expected average 14 weeks
the factor to make atrial fibrillation recur
we will perform multivariate regression analysis to know which factor makes atrial fibrillation recur irrespective of intervention method.
Measured: 3 months later after electrical cardioversion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Responsible party
- Principal investigator, Weon Kim, Kyunghee University Medical Center
- Investigators
- Weon Kim, Professor, Principal investigator, Kyunghee University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110537
- Sponsor's protocol ID
- HI13C0580
- Status last verified
- Apr 2014
- First submitted
- 6 Apr 2014
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee SM, Leem J, Park JH, Yoon KH, Woo JS, Lee JM, Kim JB, Kim W, Lee S. Close look at the experiences of patients enrolled in a clinical trial of acupuncture treatment for atrial fibrillation in Korea: a qualitative study nested within a randomised controlled trial. BMJ Open. 2017 Feb 3;7(2):e013180. doi: 10.1136/bmjopen-2016-013180.
PubMed 28159849Park J, Kim HS, Lee SM, Yoon K, Kim WS, Woo JS, Lee S, Kim JB, Kim W. Acupuncture antiarrhythmic effects on drug refractory persistent atrial fibrillation: study protocol for a randomized, controlled trial. Evid Based Complement Alternat Med. 2015;2015:613970. doi: 10.1155/2015/613970. Epub 2015 Feb 17.
PubMed 25784948
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02110537
- Acronym / sponsor ID
- HI13C0580
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Atrial fibrillation, Acupuncture, Recurrence, Electrical cardioversion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Study start
- Mar 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Acupuncture + flecainide | Experimental | Procedure: Active Acupuncture, Drug: flecainideThe participants in this group receive verum acupuncture treatment once a week for 10 weeks and flecainide 75 mg twice daily. |
| Sham acupuncture + flecainide | Sham comparator | Procedure: Sham acupuncture, Drug: flecainideThe participants in this group receive sham acupuncture treatment once a week for 10 weeks and flecainide 75 mg twice daily. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Persistent AF lasting ≥ 7 days
- Ages in 20-75 years
- Resistant with antiarrhythmic drugs
- Written informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active AcupunctureActive 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. | Procedure or surgery | Active Acupuncture + flecainide |
| Sham acupunctureFor 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. | Procedure or surgery | Sham acupuncture + flecainide |
| flecainideAlso: tambocorBoth 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. | Drug | Active Acupuncture + flecainide, Sham acupuncture + flecainide |
Primary outcome
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.
4 secondary outcomes
Changes in function and volume of left atrium and left atrial appendage evaluated by echocardiography
Time frame: 3 months after electrical cardioversion
Change of inflammation marker (hsCRP)
Time frame: 3 months after electrical cardioversion
Number of Participants with Adverse Events (AEs)
Time frame: Participants will be followed for the duration of this study, an expected average 14 weeks
the factor to make atrial fibrillation recur
Time frame: 3 months later after electrical cardioversion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2014.
- Derived from this study: PubMed 28159849Lee SM, Leem J, Park JH, Yoon KH, Woo JS, Lee JM, Kim JB, Kim W, Lee S. Close look at the experiences of patients enrolled in a clinical trial of acupuncture treatment for atrial fibrillation in Korea: a qualitative study nested within a randomised controlled trial. BMJ Open. 2017 Feb 3;7(2):e013180. doi: 10.1136/bmjopen-2016-013180.
- Derived from this study: PubMed 25784948Park J, Kim HS, Lee SM, Yoon K, Kim WS, Woo JS, Lee S, Kim JB, Kim W. Acupuncture antiarrhythmic effects on drug refractory persistent atrial fibrillation: study protocol for a randomized, controlled trial. Evid Based Complement Alternat Med. 2015;2015:613970. doi: 10.1155/2015/613970. Epub 2015 Feb 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weon Kim, Professor principal investigator
Kyunghee University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Acupuncture and flecainide in people with Persistent Atrial Fibrillation, run by Kyunghee University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weon Kim, Professor (82-2-958-8176, mylovekw@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02110537, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2014.