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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Giant T-wave Electrical Alternans

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Giant T-wave electrical alternans conventional plus mexiletine therapy

It is proposed that patients presenting with giant TWA-triggered VT/VF patients to be randomized to conventional treatment and conventional plus mexiletine treatment, respectively.

Group Type EXPERIMENTAL

Mexiletine

Intervention Type DRUG

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

Conventional therapy

Intervention Type OTHER

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

Giant T-wave electrical alternans conventional therapy

Conventional treatment in the control group according to the guidelines for the management of ventricular arrhythmias (2017 AHA/ACC/HRS)

Group Type ACTIVE_COMPARATOR

Conventional therapy

Intervention Type OTHER

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

Interventions

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Mexiletine

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

Intervention Type DRUG

Conventional therapy

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of macroscopic TWA

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No