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

NCT05619120 | Recruiting

• 1 other identifier: XJTU1AF2021CRF-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Giant T-wave Electrical Alternans

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• Length of hospital stay

  About 7 days after administration.

• Change in the number of refractory cases

  At administration,1，2，3，4，5，6，7 days after administration.

Study Arms (2)

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.

Drug: Mexiletine; Other: Conventional therapy

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)

Other: Conventional therapy

Interventions

Mexiletine DRUG

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

Giant T-wave electrical alternans conventional plus mexiletine therapy

Conventional therapy OTHER

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

Giant T-wave electrical alternans conventional plus mexiletine therapy; Giant T-wave electrical alternans conventional therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of macroscopic TWA

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xian Jiantong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Interventions

Mexiletine

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Phenyl Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Guoliang Li

  First Affiliated Hospital of Xi'an Jiaotong University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guoliang Li

CONTACT

0086-13759982523; 13759982523@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2019
• First Posted: November 16, 2022
• Study Start: January 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)