Transcutaneous electrical vagus nerve stimulation to suppress premature ventricular complexes (TREAT PVC) : study protocol for a multi-center, double-blind, randomized controlled trial
© 2023. BioMed Central Ltd., part of Springer Nature..
BACKGROUND: The autonomic nervous system can be responsible for the initiation and maintenance of arrhythmias. Low-level tragus stimulation (LLTS), a noninvasive form of autonomic neuromodulation, has been shown to be effective in treating atrial fibrillation. We intended to treat frequent premature ventricular complexes (PVCs) with LLTS.
METHODS AND DESIGN: The present study will be a prospective multicenter, double-blind, randomized, controlled trial to assess the antiarrhythmic effects of LLTS on frequent PVCs in patients without structured heart disease (SHD). A total of 100 patients with PVC burden > 10% will be randomly assigned to the active or sham LLTS in 1:1 fashion and receive the proposed intervention for 6 months. The primary outcome is PVC burden at 6 months as assessed by 10 days of continuous ambulatory electrocardiographic monitoring. Secondary outcomes include heart rate variability (HRV), quality of life, skin sympathetic nerve activity, and inflammatory markers. Adverse events will also be recorded.
DISCUSSION: The present trial will be the first to evaluate the effect of LLTS on frequent PVCs on patients without SHD. LLTS may serve as a low-cost, minimal-risk, and non-invasive alternative to conventional antiarrhythmic therapy.
TRIAL REGISTRATION: ClinicalTrial.gov NCT04909528. Registered on 17 June 2021. World health organization trial registration data set was shown in Supplementary Table 1.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:24 |
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| Enthalten in: |
Trials - 24(2023), 1 vom: 23. Okt., Seite 683 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Cai, Cheng [VerfasserIn] |
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| Links: |
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| Themen: |
Clinical Trial Protocol |
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| Anmerkungen: |
Date Completed 30.10.2023 Date Revised 21.11.2023 published: Electronic ClinicalTrials.gov: NCT04909528 Citation Status MEDLINE |
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| doi: |
10.1186/s13063-023-07713-2 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
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| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023. BioMed Central Ltd., part of Springer Nature. | ||
| 520 | |a BACKGROUND: The autonomic nervous system can be responsible for the initiation and maintenance of arrhythmias. Low-level tragus stimulation (LLTS), a noninvasive form of autonomic neuromodulation, has been shown to be effective in treating atrial fibrillation. We intended to treat frequent premature ventricular complexes (PVCs) with LLTS | ||
| 520 | |a METHODS AND DESIGN: The present study will be a prospective multicenter, double-blind, randomized, controlled trial to assess the antiarrhythmic effects of LLTS on frequent PVCs in patients without structured heart disease (SHD). A total of 100 patients with PVC burden > 10% will be randomly assigned to the active or sham LLTS in 1:1 fashion and receive the proposed intervention for 6 months. The primary outcome is PVC burden at 6 months as assessed by 10 days of continuous ambulatory electrocardiographic monitoring. Secondary outcomes include heart rate variability (HRV), quality of life, skin sympathetic nerve activity, and inflammatory markers. Adverse events will also be recorded | ||
| 520 | |a DISCUSSION: The present trial will be the first to evaluate the effect of LLTS on frequent PVCs on patients without SHD. LLTS may serve as a low-cost, minimal-risk, and non-invasive alternative to conventional antiarrhythmic therapy | ||
| 520 | |a TRIAL REGISTRATION: ClinicalTrial.gov NCT04909528. Registered on 17 June 2021. World health organization trial registration data set was shown in Supplementary Table 1 | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Neuromodulation | |
| 650 | 4 | |a Premature ventricular complexes | |
| 650 | 4 | |a Randomized controlled trial | |
| 650 | 4 | |a Tragus stimulation | |
| 700 | 1 | |a Wu, Nan |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Gang |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Shu |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Wenjie |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Minglong |e verfasserin |4 aut | |
| 700 | 1 | |a Po, Sunny S |e verfasserin |4 aut | |
| 700 | 0 | |a TREAT PVC investigators |e verfasserin |4 aut | |
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