Skip to content

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05619120
Enrollment
50
Registered
2022-11-16
Start date
2023-01-01
Completion date
2025-12-31
Last updated
2024-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Giant T-wave Electrical Alternans

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.

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)

Sponsors

First Affiliated Hospital Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in the occurrence of macroscopic TWAat 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.

Secondary

MeasureTime frameDescription
Length of hospital stayAbout 7 days after administration.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.
Change in the number of refractory casesAt administration,1,2,3,4,5,6,7 days after administration.The number of cases in the group requiring ICD for ventricular arrhythmia episodes. The data is obtained from the medical records.

Countries

China

Contacts

Primary ContactGuoliang Li
13759982523@163.com0086-13759982523

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026