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

Last updated: February 25, 2019
Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

4

Condition

Chest Pain

Heart Disease

Fast Heart Rate (Tachycardia)

Treatment

N/A

Clinical Study ID

NCT03855826
NTFS01
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with persistent ventricular tachycardia or ventricular fibrillation who havea combined physical heart disease, or who have a conventional drug ineffective orpersistent idiopathic ventricular tachycardia with amiodarone indications;

  • Age ≥ 18 years old, gender is not limited.

Exclusion

Exclusion Criteria:

  • Patients with prolonged ventricular tachycardia with QT interval and patients with QTcinterval 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

Total Participants: 756
Study Start date:
January 15, 2019
Estimated Completion Date:
January 30, 2020

Study 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.

Connect with a study center

  • Shenyang Military Region General Hospital

    Shenyang, Liaoning
    China

    Active - Recruiting

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