Ventricular Fibrillation, Ventricular Tachycardia
Conditions
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.
Interventions
DRUGAmiodarone
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.
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.
Sponsors
Sichuan Baili Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of efficacy | 24 hours after administration. | Efficacy of drugs in each group within 24 hours after administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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% |
| Number of electrical cardioversion used during the treatment | 24 hours after administration. | Number of electrical cardioversion |
| 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% |
| 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 |
| 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. |
Countries
China
Contacts
Primary ContactJing Xiong
Outcome results
None listed