Status:
COMPLETED
Antazoline in Rapid Cardioversion of Paroxysmal Atrial Fibrillation
Lead Sponsor:
National Institute of Cardiology, Warsaw, Poland
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Detailed Description
Antazoline is a first generation antihistaminic agent with chinidin-like properties. When administered intravenously, antazoline exerts a strong antiarrhythmic effect on supraventricular arrhythmia es...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01527279
Start Date
November 1 2012
End Date
March 1 2015
Last Update
May 22 2015
Active Locations (1)
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1
Institute of Cardiology, II Dept. of Coronary Heart Disease
Warsaw, Poland, 02-637