Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Frequent Premature Ventricular Complexes: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Premature Ventricular Complexes
- Sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- the proportion of participants with a 50% decrease of PVCs from baseline
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
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.
Investigators
Jiani Wu
Dr
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Eligibility Criteria
Inclusion Criteria
- •Diagnosed as frequent premature ventricular contractions;
- •2 ≤ Lown level ≤ 4A;
- •18 ≤ age ≤ 75;
- •Volunteered to participant
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
the proportion of participants with a 50% decrease of PVCs from baseline
Time Frame: 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.
Secondary Outcomes
- 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.)