TAES for FPVCs: a Pragmatic, Randomized Controlled Trial
- Conditions
- Premature Ventricular Complexes
- Interventions
- Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham-TAVNS)Device: Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS)
- Registration Number
- NCT04415203
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- Diagnosed as frequent premature ventricular contractions;
- 2 ≤ Lown level ≤ 4A;
- 18 ≤ age ≤ 75;
- Volunteered to participant
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham-TAVNS plus usual care Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham-TAVNS) Sham-TAVNS on Erzhong and Xin (Auricular Acupuncture Point); the same acupoints as the treatment group without any current. Usual Care: usual medicine treatment for PVCs. TAVNS plus usual care Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS) TAVNS on Erzhong and Xin (Auricular Acupuncture Point with Vagus nerve distribution); Usual Care: usual medicine treatment for PVCs.
- Primary Outcome Measures
Name Time Method the proportion of participants with a 50% decrease of PVCs from baseline 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 Outcome Measures
Name Time Method the change from baseline in PVCs week 6, week 18 The PVCs will be assessed by a 24-hour Holter monitoring. The investigators will calculate the decrease of PVCs between baseline and week 6/18.
the proportion of participants with a 75% decrease of PVCs from baseline week 6, week 18 The PVCs will be assessed by a 24-hour Holter monitoring. The investigators will calculate the decrease of PVCs between baseline and week 6/18, then we will obtain the proportion of patients with a 75% decrease.
the change from baseline in total cardiac impulse week 6, week 18 The total cardiac impulse will be assessed by a 24-hour Holter monitoring. The investigators will calculate the change of total cardiac impulse between baseline and week 6/18.
the change from baseline in supraventricular premature contractions week 6, week 18 The change from baseline in supraventricular premature contractions will be assessed by a 24-hour Holter monitoring. The investigators will calculate the change of supraventricular premature contractions between baseline and week 6/18.
the score change from baseline in the symptom of chest tightness week 6, week 18. The symptom of chest tightness will be assessed by a 10-scale VAS from 0 to 10, a higher score indicates a more severe symptom of chest tightness. The investigators will calculate the score change of chest tightness between baseline and week 6/18.
the score change from baseline in the symptom of dizziness week 6, week 18. The symptom of dizziness will be assessed by a 10-scale VAS from 0 to 10, a higher score indicates a more severe symptom of dizziness. The investigators will calculate the score change of dizziness between baseline and week 6/18.
the proportion of participants with a 50% decrease of PVCs from baseline week 18 The PVCs will be assessed by a 24-hour Holter monitoring. The investigators will calculate the decrease of PVCs between baseline and week 18 (at the end of the follow-up period), then we will obtain the proportion of patients with a 50% decrease.
the score change from baseline in the SAS week 6, week 18. Self Anxiety Scale (SAS) contains 20 items scored from 25 to 100. Score 50-59 was classified as mild anxiety; Score 60-69 as moderate anxiety, and score ≥ 70 as severe anxiety.
the score change from baseline in the symptom of palpitation week 6, week 18. The symptom of palpitation will be assessed by a 10-scale VAS from 0 to 10, a higher score indicates a more severe symptom of palpitation. The investigators will calculate the score change of palpitation between baseline and week 6/18.
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 symptom of palpitation/chest tightness/dizziness/insomnia will be assessed by a 10-scale VAS from 0 to 10. Score 4-6 are defined as the moderate level, Score 7-10 are defined as the severe level. The investigators will calculate the change of the proportion of patients with the moderate/severe symptoms between baseline and week 6/18.
the score change from baseline in the SDS week 6, week 18. Self Depression Scale (SDS) contains 20 items scored from 25 to 100. Score 53-62 was classified as mild depression; Score 63-72 as moderate depression, and score ≥ 73 as severe depression.
the score change from baseline in SF-36 week 6, week 18. The SF-36 questionnaire contains eight scales with two measures: physical and mental health. The physical health includes four scales of physical functioning (PF), role-physical (RF), bodily pain (BP), and general health (GH). The mental health is composed of vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH).
SF-36 scores from 0 to 100, higher scores indicate better health status.the score change from baseline in the symptom of insomnia week 6, week 18. The symptom of insomnia will be assessed by a 10-scale VAS from 0 to 10, a higher score indicates a more severe symptom of insomnia. The investigators will calculate the score change of insomnia between baseline and week 6/18.
Trial Locations
- Locations (1)
Guang'anmen Hospita, China Academy of Chinese Medical Sciences
🇨🇳Beijing, Beijing, China