Giant T-wave Electrical AlternansNCT05619120
The Effect of Late Na Current Blocker Mexiletine on Giant T-wave Electrical Alternans(STOP-TWA)
A study testing Mexiletine and Conventional therapy in people with Giant T-wave Electrical Alternans, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Giant T-wave Electrical Alternans
- What is being tested?
- Mexiletine and Conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of macroscopic TWA
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xian Jiantong University
Xi'an, Shaanxi, 710061
Guoliang Li, 008613759982523, liguoliang_med@163.com
About this study
Official title: Potential of Late Na Current Blocker Mexilate on Giant T-wave Electrical Alternans and Subsequent Ventricular Arrhythmias: a Multicenter, Randomized, Prospective Study
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
- Being tested
- Mexiletine, Conventional therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MexiletineDrug
Mexiletine (150mg, bid, po) is given to patients who have been divided into Mexiletine group.
Conventional therapyOther
Treatment according to the guidelines for the management of ventricular arrhythmias (2017 AHA/ACC/HRS)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at administration,1，2，3，4，5，6，7 days after administration.
Secondary outcomes (2)
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.
Measured: About 7 days after administration.
Change in the number of refractory cases
The number of cases in the group requiring ICD for ventricular arrhythmia episodes. The data is obtained from the medical records.
Measured: At administration,1，2，3，4，5，6，7 days after administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start1 Jan 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant T-wave Electrical AlternansStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guoliang Li, Principal investigator, First Affiliated Hospital of Xi'an Jiaotong University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619120
- Sponsor's protocol ID
- XJTU1AF2021CRF-001
- Status last verified
- Apr 2024
- First submitted
- 24 Nov 2019
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential of Late Na Current Blocker Mexilate on Giant T-wave Electrical Alternans and Subsequent Ventricular Arrhythmias: a Multicenter, Randomized, Prospective Study
- ClinicalTrials.gov ID
- NCT05619120
- Acronym / sponsor ID
- XJTU1AF2021CRF-001
- Conditions
- Giant T-wave Electrical Alternans
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Giant T-wave electrical alternans conventional plus mexiletine therapy | Experimental | Drug: Mexiletine, Other: Conventional therapyIt 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 | Other: Conventional therapyConventional treatment in the control group according to the guidelines for the management of ventricular arrhythmias (2017 AHA/ACC/HRS) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of macroscopic TWA
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MexiletineMexiletine (150mg, bid, po) is given to patients who have been divided into Mexiletine group. | Drug | Giant T-wave electrical alternans conventional plus mexiletine therapy |
| Conventional therapyTreatment according to the guidelines for the management of ventricular arrhythmias (2017 AHA/ACC/HRS) | Other | Giant T-wave electrical alternans conventional plus mexiletine therapy, Giant T-wave electrical alternans conventional therapy |
Primary outcome
Change in the occurrence of macroscopic TWA
Time frame: 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.
2 secondary outcomes
Length of hospital stay
Time frame: About 7 days after administration.
Change in the number of refractory cases
Time frame: At administration,1，2，3，4，5，6，7 days after administration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guoliang Li principal investigator
First Affiliated Hospital of Xi'an Jiaotong University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mexiletine and Conventional therapy in people with Giant T-wave Electrical Alternans, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guoliang Li (0086-13759982523 ext. 13759982523, 13759982523@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the occurrence of macroscopic TWA (time frame: at administration,1，2，3，4，5，6，7 days after administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.