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临床试验/NCT05619120
NCT05619120招募中不适用

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

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Change in the occurrence of macroscopic TWA

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of macroscopic TWA

排除标准

  • 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.

研究组 & 干预措施

Giant T-wave electrical alternans conventional plus mexiletine therapy

Experimental

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.

干预措施: Mexiletine (Drug)

Giant T-wave electrical alternans conventional plus mexiletine therapy

Experimental

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.

干预措施: Conventional therapy (Other)

Giant T-wave electrical alternans conventional therapy

Active Comparator

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

干预措施: Conventional therapy (Other)

结局指标

主要结局

Change in the occurrence of macroscopic TWA

时间窗: at administration,1,2,3,4,5,6,7 days after administration.

Macroscopic TWA occurring on conventional ECG (12-lead ECG, telemetry ECG, or holter ECG) with visually identifiable TWA Diagnosis confirmed by at least 3 leading ECG specialists. The data is obtained from the medical records.

次要结局

  • Change in the number of refractory cases(At administration,1,2,3,4,5,6,7 days after administration.)
  • Length of hospital stay(About 7 days after administration.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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