Evaluation of the Efficacy and Safety of Nifekalant Hydrochloride (NIF) Injection.
- Conditions
- Ventricular TachycardiaVentricular Fibrillation
- Interventions
- Registration Number
- NCT03855826
- Lead Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Brief Summary
Efficacy and safety evaluation of amiodarone and Nifekalant hydrochloride(NIF) for the treatment of ventricular tachycardia and ventricular fibrillation.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 756
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nifekalant Hydrochloride Nifekalant hydrochloride 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. Amiodarone Amiodarone 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).
- Primary Outcome Measures
Name Time Method The rate of efficacy 24 hours after administration. Efficacy of drugs in each group within 24 hours after administration.
- Secondary Outcome Measures
Name Time Method The average time from the start of administration to the last VT/VF no longer occurs 24 hours after administration. Patients who changed drugs will not be included statistics on this indicator.
LVEF Before administration, and 24h to 72h after the start of administration. Echocardiography
The efficiency rate without adjusting the drug dose 24 hours after administration. number of patients who no longer relapse after using the drug / total number of patients in the group × 100%
The success rate of DC in patients with first invalid cardioversion in the two groups 24 hours after administration. Number of patients ewith valid DC after the first invalid DC / Total number of patients with first invalid DC in this group × 100%
Number of electrical cardioversion used during the treatment 24 hours after administration. Number of electrical cardioversion
Survival rate 30 days after administration. Survival rate of the two groups of patients
Number of ventricular tachycardia/ventricular fibrillation episodes Within 72 hours after drug administration. Number of ventricular tachycardia/ventricular fibrillation episodes .
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 number of patients who need to continue the intravenous research drug after 24 hours in the two groups
The effective rate of the drug in each group within 72 hours after administration 72 hours after administration. The effective rate of the drug in each group within 72 hours after administration.
Trial Locations
- Locations (1)
Shenyang Military Region General Hospital
🇨🇳Shenyang, Liaoning, China