Evaluation of the Efficacy and Safety of Nifekalant Hydrochloride (NIF) Injection.

Study Overview
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Brief Summary
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Efficacy and safety evaluation of amiodarone and Nifekalant hydrochloride(NIF) for the treatment of ventricular tachycardia and ventricular fibrillation.

Detailed Description
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After patients are hospitalized, they will be treated as usual in addition to antiarrhythmic drugs. DC will be performed again according to normal procedures for patients who were ineffective. Arrhythmia drugs can only be used with nifekalant or amiodarone at random.

Official Title
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Evaluation of the Efficacy and Safety of Nifekalant Hydrochloride (NIF) Injection in the Treatment of Ventricular Tachycardia and Ventricular Fibrillation. A Multicenter, Randomized, Controlled, Open-label, Clinical Trial.

Conditions
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Ventricular Tachycardia, Ventricular Fibrillation

Intervention / Treatment
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* Drug: Nifekalant hydrochloride
* Drug: Amiodarone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with persistent ventricular tachycardia or ventricular fibrillation who have a combined physical heart disease, or who have a conventional drug ineffective or persistent idiopathic ventricular tachycardia with amiodarone indications; Age ≥ 18 years old, gender is not limited. Exclusion Criteria: Patients with prolonged ventricular tachycardia with QT interval and patients with QTc interval of more than 500 ms before administration; Patients with torsades de pointes (Tdp); Patients with Brugada syndrome; Patients with severe atrioventricular block and without pacing protection; Patients with hypertrophic cardiomyopathy (HCM) with ventricular septal thickness or (and) left ventricular wall ≥ 15 mm; Pregnant or lactating women; Patients who are not suitable for the study, considered by investigators.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nifekalant Hydrochloride<br>Nifekalant hydrochloride (50mg) should be dissolved into a 50ml dilution solution (0.9% sodium chloride injection or 5% glucose injection), and configured as 1mg/ml solution of nificaine hydrochloride. The dosage should be taken as needed. The diluted solution should be used within 24 hours. The amount of fluid per hour should not exceed 50ml when intravenously infused. It is recommended to use intravenous pump. | Drug: Nifekalant hydrochloride<br>* Both groups were given conventional treatment except for arrhythmia drugs.Only nyficarine hydrochloride or amiodarone hydrochloride could be used according to random results, and the antiarrhythmic drugs should be replaced according to the protocol rules.<br>* Other names: Nifekalant Hydrochloride for Injection;|
| Active Comparator: Amiodarone<br>The concentration of more than 2 ampoule amiodarone injection in 500 ml (only isotonic grape solution) is suitable. Amiodarone should be administered as far as possible via the central venous route (administered separately). | Drug: Amiodarone<br>* Both groups were given conventional treatment except for arrhythmia drugs.Only nyficarine hydrochloride or amiodarone hydrochloride could be used according to random results, and the antiarrhythmic drugs should be replaced according to the protocol rules.<br>* Other names: Amiodarone hydrochloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of efficacy | Efficacy of drugs in each group within 24 hours after administration. | 24 hours after administration. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficiency rate without adjusting the drug dose | number of patients who no longer relapse after using the drug / total number of patients in the group × 100% | 24 hours after administration. | 
| Number of electrical cardioversion used during the treatment | Number of electrical cardioversion | 24 hours after administration. | 
| The success rate of DC in patients with first invalid cardioversion in the two groups | Number of patients ewith valid DC after the first invalid DC / Total number of patients with first invalid DC in this group × 100% | 24 hours after administration. | 
| The average time from the start of administration to the last VT/VF no longer occurs | Patients who changed drugs will not be included statistics on this indicator. | 24 hours after administration. | 
| LVEF | Echocardiography | Before administration, and 24h to 72h after the start of administration. | 
| Survival rate | Survival rate of the two groups of patients | 30 days after administration. | 
| Number of ventricular tachycardia/ventricular fibrillation episodes | Number of ventricular tachycardia/ventricular fibrillation episodes . | Within 72 hours after drug administration. | 
| The number of patients who need to continue the intravenous research drug after 24 hours in the two groups | The number of patients who need to continue the intravenous research drug after 24 hours in the two groups | 24 hours after the start of the adminstration. | 
| The effective rate of the drug in each group within 72 hours after administration | The effective rate of the drug in each group within 72 hours after administration. | 72 hours after administration. |