Recent-onset of atrial fibrillation/flutter
Conditions
Interventions
Nifekalant group:Nifekalant
Amiodarone group:Amiodarone
Sponsors
Fuwai Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
26 Years to 82 Years
Inclusion criteria
Inclusion criteria: (1) Age =18 years old, regardless of gender; (2) Weight =45kg and = 100kg; (3) Patients (including patients with organic heart disease) with recent-onset atrial fibrillation and atrial flutter which are ineffective or inapplicable to other drugs and persist for =48h and =3h; (4) Patients who can obtain the informed consent of the patients themselves or their families after fully explaining them before the start of the study.
Exclusion criteria
Exclusion criteria: (1) patients with anticoagulant taboo; (2) Patients with contraindication of cardioversion; (3) Patients with hemodynamic instability; (4) Patients who have used ß -adrenergic blocking agent, non-dihydropyridine calcium antagonist or digoxin within =2 hours before drug administration; Or class I or class III antiarrhythmic drugs administered within the 24 hours prior to study initiation, such as amiodarone; (5) Patients who regularly used amiodarone within 30 days before drug administration; (6) Patients with 6)QRS longer than 0.14 s and no pacemaker; (7) Patients with ventricular rate less than 50 times/min and no cardiac pacemaker; (8) Patients with baseline QTc intervals greater than 0.480s in women and 0.470s in men; (9) Patients with NYHA Class IV cardiac function; (10) patients with acute coronary syndrome; (11) Patients with diastolic blood pressure lower than 60mmHg or systolic blood pressure lower than 95mmHg; (12) Patients with uncorrected hypokalemia (blood potassium < 3.5mmol/L); (13) Pregnant or lactating female patients or those with recent family planning; (14) Other factors that were not considered suitable for participation in this study were found by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of cardioversion for each group; | — |
Secondary
| Measure | Time frame |
|---|---|
| Average time to AF conversion to sinus rhythm;Proportion of subjects in each group who discontinued atrial fibrillation or flutter within 4 hours of dosing and did not relapse;The percentage of heart rate (HR) changes at 10 minutes, 1 hour, 2 hours, 3 hours, and 4 hours after drug administration compared with the baseline of drug administration ;For subjects with "no recurrence" of atrial fibrillation, the improvement of symptoms of atrial fibrillation at 4 hours after the start of drug administration was evaluated compared with that before drug administration.;Rate of cardioversion at 2 hours; | — |
Countries
China
Contacts
Public ContactYanmin Yang
Fuwai Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed