Clinical trial NCT02110537: Acupuncture in Persistent Atrial Fibrillation
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: Atrial fibrillation
Acupuncture
Recurrence
Electrical cardioversion
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: Ministry of Health & Welfare, Korea
First posted: 2014-04-10
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: Recurrence of atrial fibrillation evaluated on serial electrocardiography and 48 hour holter monitoring after sinus conversion by electrical cardioversion
timeFrame: 3 months after electrical cardioversion
Secondary outcomes:
measure: Changes in function and volume of left atrium and left atrial appendage evaluated by echocardiography
timeFrame: 3 months after electrical cardioversion
measure: Change of inflammation marker (hsCRP)
timeFrame: 3 months after electrical cardioversion
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Participants will be followed for the duration of this study, an expected average 14 weeks
measure: the factor to make atrial fibrillation recur
timeFrame: 3 months later after electrical cardioversion
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center
state: Dongdaemun-gu
Study officials:
affiliation: Kyunghee University Medical Center
name: Weon Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Park 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.