Antazoline in Rapid Cardioversion of Paroxysmal Atrial Fibrillation

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this randomized, double blind, placebo-controlled, superiority clinical trial was to assess clinical efficacy of antazoline in rapid conversion of atrial fibrillation during observation sinus rhythm.

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

Details

• Lead Sponsor: Institute of Cardiology, Warsaw, Poland
• Treatments: Antazoline

Criteria

Inclusion Criteria:

• Written informed consent for participating in the study and written standard version of informed consent for cardioversion accepted in Institute of Cardiology, Warsaw, Poland

• Age above 18 and good general condition

• Potassium level over 3.5 mmol/l

• Stable cardio-pulmonary state on enrollment

• In case of unclear history of heart failure or suspicion of impaired left ventricle function echocardiography is indicated prior to enrollment

• A long-term antiarrhythmic drug therapy is allowed

Exclusion Criteria:

• Lack of written informed consent

• Antazoline allergy

• AF related to significant valvular disease

• Clinically significant heart failure or ejection fraction < 55%

• Diastolic blood pressure (BP) < 100mmHg

• History of significant bradyarrhythmia not treated with permanent pacemaker

• QT prolongation over 440ms or QTc (Bazett's formula) over population norm

• Tachycardia > 160'

• Advanced liver or kidney failure

• Acute coronary syndrome, coronary artery by-pass graft, stroke or transient ischemic attack within 30 days before enrollment

• Preexcitation in ECG not treated by radiofrequency ablation of accessory pathway

• Signs and symptoms of ischemia related to AF

• An investigational drug used within 30 days before enrollment

• Pregnancy or breast feeding