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

• Status: Unknown status
• Trial end date: 2020-01-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
• Treatments: Amiodarone; Nifekalant

Criteria

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.