RecruitingNot ApplicableNCT05619120

The Effect of Late Na Current Blocker Mexiletine on Giant T-wave Electrical Alternans(STOP-TWA)

Potential of Late Na Current Blocker Mexilate on Giant T-wave Electrical Alternans and Subsequent Ventricular Arrhythmias: a Multicenter, Randomized, Prospective Study


Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Enrollment

50 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The electrocardiogram is one of the most basic tests for cardiovascular disease. T wave alternans (TWA), which reflects abnormal ventricular repolarization, can easily trigger ventricular tachycardia (VT) and ventricular fibrillation (VF), which are important warning clues for sudden cardiac death (SCD). The late sodium current (INaL) is an important component of the frequency-dependent regulation of cardiac repolarization, and various causes of delayed repolarization can increase INaL. Our study on long QT syndrome (LQTS) found that INaL abnormalities can lead to abnormal myocardial repolarization, producing a giant TWA that triggers VT and VF. VT and VF, and INaL inhibition by the INaL blocker mexilate can terminate this process. This suggests that pharmacological blockade of INaL may be a potential target for the prevention of SCD by ameliorating the different causes of giant TWA and its triggering ventricular arrhythmic events. In this study, we propose to randomize patients with VT/VF triggered by giant TWA to conventional treatment and conventional treatment adds mexiletine treatment to compare the effects of the two treatment regimens on giant TWA and its triggered nonsustained VT, sustained VT, and VF; at the same time, we will compare the effects of mexiletine on giant TWA and its triggered ventricular arrhythmias of various etiologies by intra-group control before and after treatment. The safety and efficacy of the treatment of TWA and its triggered ventricular arrhythmias are compared.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria1

  • Clinical diagnosis of macroscopic TWA

Exclusion Criteria3

  • The patients who do not agree to participate in the study,
  • Patients with acute coronary syndrome or with progressive myocardial ischemia according to clinical manifestations, electrocardiogram or myocardial biochemical markers;
  • Those who have used other class I antiarrhythmic drugs or who are contraindicated by mexiletine.

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Interventions

DRUGMexiletine

Mexiletine (150mg, bid, po) is given to patients who have been divided into Mexiletine group.

OTHERConventional therapy

Treatment according to the guidelines for the management of ventricular arrhythmias (2017 AHA/ACC/HRS)


Locations(1)

First Affiliated Hospital of Xian Jiantong University

Xi'an, Shaanxi, China

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NCT05619120