Clinical trial NCT04415203: TAES for FPVCs: a Pragmatic, Randomized Controlled Trial
Official title: Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Frequent Premature Ventricular Complexes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Ventricular Complexes
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: China Association for Science and Technology
First posted: 2020-06-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: the proportion of participants with a 50% decrease of PVCs from baseline
timeFrame: week 6
Secondary outcomes:
measure: the proportion of participants with a 50% decrease of PVCs from baseline
timeFrame: week 18
measure: the proportion of participants with a 75% decrease of PVCs from baseline
timeFrame: week 6, week 18
measure: the change from baseline in PVCs
timeFrame: week 6, week 18
measure: the change from baseline in total cardiac impulse
timeFrame: week 6, week 18
measure: the change from baseline in supraventricular premature contractions
timeFrame: week 6, week 18
measure: the score change from baseline in the symptom of palpitation
timeFrame: week 6, week 18.
measure: the score change from baseline in the symptom of chest tightness
timeFrame: week 6, week 18.
measure: the score change from baseline in the symptom of dizziness
timeFrame: week 6, week 18.
measure: the score change from baseline in the symptom of insomnia
timeFrame: week 6, week 18.
measure: the change of the proportion of participants with moderate/severe symptoms of palpitation, chest tightness, dizziness or insomnia from baseline
timeFrame: week 6, week 18.
measure: the score change from baseline in the SAS
timeFrame: week 6, week 18.
measure: the score change from baseline in the SDS
timeFrame: week 6, week 18.
measure: the score change from baseline in SF-36
timeFrame: week 6, week 18.
Other outcomes:
measure: subgroup analysis of ages
timeFrame: week 6
measure: subgroup analysis of gender
timeFrame: week 6
measure: subgroup analysis of the severity of PVCs
timeFrame: week 6
measure: the proportion of participants with adverse events
timeFrame: week 6, week 18
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospita, China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Jiani Wu
role: PRINCIPAL_INVESTIGATOR
References: