Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Frequent Premature Ventricular Complexes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- the proportion of participants with a 50% decrease of PVCs from baseline
研究概览
简要总结
This prospective, randomized controlled trial aims to evaluate the efficacy and safety of Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS) for patients with frequent premature ventricular coomplexes (FPVCs). Ninety participants will be randomized to TAVNS group and sham-TAVNS group with the ratio of 1:1. They will receive TAVNS plus usual care or sham-TAVNS 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 complexes (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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as frequent premature ventricular contractions;
- •2 ≤ Lown level ≤ 4A;
- •18 ≤ age ≤ 75;
- •Volunteered to participant
排除标准
- •Severe valvular disease, congenital heart disease, pericardial disease, hypertrophic cardiomyopathy, unstable angina pectoris, acute myocardial infarction, myocarditis, aneurysm, congestive heart failure decompensation period (NYHA grade III or VI), cardiogenic shock, cerebrovascular disease, hematopoietic system disease, severe mental disease;
- •Bradycardia, including pathologic sinus node syndrome, degree II or greater atrioventricular block;
- •Those who have already had pacemaker or percutaneous coronary intervention, or who plan to have pacemaker or percutaneous coronary intervention;
- •Pregnant or lactating women;
- •Local sensory deficit, or allergic to current;
- •May be allergic to percutaneous patches；
- •Blood pressure ≤ 90/60 mmHg;
- •Those who have participated in other clinical trials within 3 months.
结局指标
主要结局
the proportion of participants with a 50% decrease of PVCs from baseline
时间窗: week 6
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.
次要结局
- the change from baseline in PVCs(week 6, week 18)
- the proportion of participants with a 75% decrease of PVCs from baseline(week 6, week 18)
- the change from baseline in total cardiac impulse(week 6, week 18)
- the change from baseline in supraventricular premature contractions(week 6, week 18)
- the score change from baseline in the symptom of chest tightness(week 6, week 18.)
- the score change from baseline in the symptom of dizziness(week 6, week 18.)
- the proportion of participants with a 50% decrease of PVCs from baseline(week 18)
- the score change from baseline in the SAS(week 6, week 18.)
- the score change from baseline in the symptom of palpitation(week 6, week 18.)
- the change of the proportion of participants with moderate/severe symptoms of palpitation, chest tightness, dizziness or insomnia from baseline(week 6, week 18.)
- the score change from baseline in the SDS(week 6, week 18.)
- the score change from baseline in SF-36(week 6, week 18.)
- the score change from baseline in the symptom of insomnia(week 6, week 18.)
研究者
Jiani Wu
Dr
Guang'anmen Hospital of China Academy of Chinese Medical Sciences