Clinical Efficacy of Potassium Canrenoate in Sinus Rhythm Restoration Among Patients With Atrial Fibrillation. (CANREN-AF)
Atrial Fibrillation, Paroxysmal
About this trial
This is an interventional treatment trial for Atrial Fibrillation, Paroxysmal focused on measuring Pharmacological cardioversion, Canrenone
Eligibility Criteria
Inclusion Criteria:
- written informed consent for enrolment
- patients aged between 40 and 75 years
- atrial fibrillation episode lasting for less than 48 hours, documented by the ECG
- potassium plasma levels < 4.5 mmol/l
- blood pressure > 120/80 mmHg
- stable cardiopulmonary status (according to attending physician's assessment)
- in case of left ventricle injury suspicion or unclear medical history of cardiac insufficiency, enrolment will be possible after echocardiographic examination
Exclusion Criteria:
- no written informed consent for enrollment
- allergy to canrenone
- cardiac insufficiency or LVEF (left ventricular ejection fraction) < 40%
- systolic BP < 120/80 mmHg
- history of canrenone treatment in the 30 days before enrollment
- average QRS rate > 160 p.m.
- advanced hepatic or renal failure
- history of acute coronary syndrome, CABG (coronary artery bypass grafting), TIA (transient ischemic attack) or stroke within the previous 30 days
- pre-excitation syndrome (which has not been treated with accessory pathway ablation).
- atrial fibrillation due to a valvular heart disease
- atrial fibrillation episode resulting in myocardial ischemia (chest pain, ischemic changes in the ECG)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo Comparator: Placebo
Experimental: canrenone
Any patient fulfilling the inclusion criteria will be prepared to pharmacological cardioversion in a standard way comprising of standard baseline 12-lead ECG, continuous ECG monitoring, periodic noninvasive blood pressure monitoring (BP) and iv line. Patients assigned to control group will be administered saline 0.9% in bolus of 10 cm3 within 2-3 minutes. After drug administration the patient will be observed for 2 hours after the last dose with exit ECG and BP measure taken at the end of observation. Further treatment of the patient will depend on clinical condition and will follow appropriate clinical guidelines.
Any patient fulfilling the inclusion criteria will be prepared to pharmacological cardioversion in a standard way comprising of standard baseline 12-lead ECG, continuous ECG monitoring, periodic noninvasive blood pressure monitoring (BP) and iv line. After administration of canrenone: dose 200 mg (1 ampule a 10 ml) within 2-3 minutes the patient will be observed for 2 hours after the dose with exit ECG and BP measure taken at the end of observation.