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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mexiletine | Drug | Mexiletine (150mg, bid, po) is given to patients who have been divided into Mexiletine group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the occurrence of macroscopic TWA | 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. | at administration,1,2,3,4,5,6,7 days after administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Comparison between two treatment groups due to the effect of ventricular arrhythmia episodes on the duration of hospitalization ( days) in patients. The data is obtained from the medical records. | About 7 days after administration. |
| Change in the number of refractory cases |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guoliang Li | Contact | 0086-13759982523 | 13759982523 | 13759982523@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Guoliang Li | First Affiliated Hospital of Xi'an Jiaotong University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xian Jiantong University | Recruiting | Xi'an | Shaanxi | 710061 | China |
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| ID | Term |
|---|---|
| D008801 | Mexiletine |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
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| Conventional therapy | Other | Treatment according to the guidelines for the management of ventricular arrhythmias (2017 AHA/ACC/HRS) |
|
The number of cases in the group requiring ICD for ventricular arrhythmia episodes. The data is obtained from the medical records. |
| At administration,1,2,3,4,5,6,7 days after administration. |
| D010636 |
| Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |