TAES for FPVCs: a Pragmatic, Randomized Controlled Trial

Официальное название

Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Frequent Premature Ventricular Complexes: A Randomized Controlled Trial

Обзор

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.

Вмешательства

• Устройство Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS)
  Patients in TAVNS group will receive TAVNS and usual care. TAVNS will be performed on Erzhong and Xin (Auricular Acupuncture Point with vagus nerve distribution) for 6 weeks by using the Huato type SDZ-V stimulator; Usual Care: usual medicine treatment for PVCs.
• Устройство Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham-TAVNS)
  Patients in sham-TAVNS group will receive sham-TAVNS and usual care. Sham-TAVNS will be also performed on Erzhong and Xin (Auricular Acupuncture Point with vegas nerve stimulation) for 6 weeks by using a special Huato type SDZ-V stimulator. We cut the inner electric wire of the stimulator; therefore, there is no current output. Usual Care: usual medicine treatment for PVCs.

Первичные конечные точки

• the proportion of participants with a 50% decrease of PVCs from baseline [Срок оценки: week 6]

Вторичные конечные точки (12)

• the proportion of participants with a 50% decrease of PVCs from baseline [Срок оценки: week 18]
• the proportion of participants with a 75% decrease of PVCs from baseline [Срок оценки: week 6, week 18]
• the change from baseline in PVCs [Срок оценки: week 6, week 18]
• the change from baseline in total cardiac impulse [Срок оценки: week 6, week 18]
• the change from baseline in supraventricular premature contractions [Срок оценки: week 6, week 18]
• the score change from baseline in the symptom of palpitation [Срок оценки: week 6, week 18.]
• the score change from baseline in the symptom of chest tightness [Срок оценки: week 6, week 18.]
• the score change from baseline in the symptom of dizziness [Срок оценки: week 6, week 18.]
• the score change from baseline in the symptom of insomnia [Срок оценки: week 6, week 18.]
• the change of the proportion of participants with moderate/severe symptoms of palpitation, chest tightness, dizziness or insomnia from baseline [Срок оценки: week 6, week 18.]
• the score change from baseline in the SAS [Срок оценки: week 6, week 18.]
• the score change from baseline in the SDS [Срок оценки: week 6, week 18.]

Критерии участия

Критерии включения

• Diagnosed as frequent premature ventricular contractions;
• 2 ≤ Lown level ≤ 4A;
• 18 ≤ age ≤ 75;
• Volunteered to participant

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Guang'anmen Hospita, China Academy of Chinese Medical Sciences — Пекин

Публикации

• Liu Y, Wei X, Wang L, Yang Y, Xu L, Sun T, Yang L, Cai S, Liu X, Qin Z, Bin L, Sun S, Lu Y, Cui J, Liu Z, Wu J. Efficacy and safety of transcutaneous auricular vagus nerve stimulation for frequent premature ventricular complexes: rationale and design of the TASC-V trial. BMC Complement Med Ther. 2024 Jul 29;24(1):288. doi: 10.1186/s12906-024-04568-1. PMID 39075454

Идентификаторы

NCT: NCT04415203 · TAESforFPVC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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