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Table 1 Inclusion and exclusion criteria

From: Clinical efficacy of potassium canreonate-canrenone in sinus rhythm restoration among patients with atrial fibrillation - a protocol of a pilot, randomized, double -blind, placebo-controlled study (CANREN-AF trial)

Inclusion criteria

• Written informed consent for enrollment

• Patients aged between 40 and 75 years

• Atrial fibrillation episode lasting for less than 48 h, documented by the ECG

• Potassium plasma level < 4.5 mmol/l

• Systolic blood pressure > 120 mmHg

• Stable cardiopulmonary status (according to attending physician’s assessment)

• In the case of left ventricle injury suspicion or unclear medical history of cardiac insufficiency, enrollment will be possible after echocardiographic examination

Exclusion criteria

• No written informed consent for enrollment

• Allergy to canrenone or spironolactone

• Cardiac insufficiency or left ventricular ejection fraction < 40%

• Systolic blood pressure ≤ 120 mmHg

• History of canrenone treatment in the 30 days before enrollment

• Average QRS rate > 160 per minute

• Advanced hepatic (international normalized ratio > 1.5, aminotransferases > 3 times above normal) or renal failure (eGFR < 40 ml/min/1.73 m2)

• History of acute coronary syndrome, coronary artery bypass grafting, 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 valvular heart disease

• Atrial fibrillation episode resulting in myocardial ischemia (chest pain, ischemic changes in the ECG)

Antiarrhythmic agents

• Rate control medications, such as β-blockers or calcium channel blockers (verapamil, diltiazem), are allowed in the preceding 2 h

• Chronic antiarrhythmic therapy is not an exclusion criterion. Atrial fibrillation episode indicates for its low efficacy

  1. ECG electrocardiogram, eGFR estimated glomerular filtration rate, QRS complex in the ECG