An open-label, randomized clinical trial comparing Etacizin versus Propafenone in Atrial Fibrillation

Prior treatment

• Any concomitant somatic or mental disease that is in a poor/un-controlled state, or, in opinion of the investigator, could bias the results of the trial, or increase the risk for adverse events.
• Patients with alcohol or drug abuse.
• Patients participating in another clinical trial currently or within 30 days before the enrolment (randomization).

Other illness

• Patients with significant structural or functional heart disease: - left ventricular hypertrophy (LVH): septum/ posterior wall ≥14 mm; - left ventricular (LV) systolic dysfunction: LV EF ≤40%; - severe aortic valve stenosis according criteria of ESC/EACTS Guidelines for the management of valvular heart disease; - heart failure: NYHA functional class III or IV; - acute coronary syndrome, recent (3 months, or less) myocardial infarction with Q wave and/or convincingly significant myocardial damage; - severe coronary artery disease without or incomplete revascularization.
• Malignancy of any location (if not in remision).
• Uncontrolled hypertension (grade III, SBP ≥180 mmHg and/or DBP ≥110 mmHg).
• Sick-sinus syndrome or severe bradycardia less than < 50 beats per minute (average rate during 24 hours or conventional surface ECG).
• 2nd- or 3rd-degree AV block or right or left bundle branch block, fixed and known Brugada syndrome.

Lab values

• Clinically significant kidney or liver impairment (Chronic Kidney Disease assessed as eGFR < 45 ml/min/1.73 m², and liver impairment assessed as > 3x upper normal limit for AST and/or ALT).
• Evidence of any significant clinical or laboratory finding, or test results that make it undesirable for the patient to participate in the study.
• Prolonged QTc (> 460ms).

Other

• Contradiction for the use of the etacizin or propafenone as per Summary of Product Characteristics, including breast feeding.
• Problems with information perception and/or completing the questionnaires.
• BMI > 30 kg/m2.
• Severe, stabile long-therm hypotension (SBP < 90 mmHg).
• Implanted pacemaker.
• Hyper or hypokalaemia.

• Male or female patients, aged 18-70 years old inclusive at the time of signing the informed consent.
• Body weight over 70 kg.
• Clinical paroxysmal or persistent atrial fibrillation confirmed by the surface 12-lead ECG or 24-h Holter monitoring.
• Females of nonchildbearing potential (postmenopausal [defined as 12 months of spontaneous amenorrhea] or pre-menopausal with documented irreversible surgical sterilisation or hysterectomy) or childbearing potential (negative pregnancy test at screening and using an effective method to avoid pregnancy, i.e., oral, injectable, transdermal or implanted hormonal contraceptives, vaginal contraceptive ring, intrauterine device/intrauterine system, vasectomised sexual partner [with confirmed negative sperm counts] or true sexual abstinence).
• Signed informed consent.
  • (for Phase II) 1. Patient qualifying for enrollment in Phase II (maintenance phase) has to be on sinus rhythm either in a result of pharmacological or pharmacological in combination with electrical cardioversion.
  • (for Phase II) 2. Patient has to be on stable treatment regimen for atrial fibrillation.