RAte Control Efficacy in Permanent Atrial Fibrillation

Study objectives:

• To show that lenient rate control is not inferior to strict rate control in terms of cardiovascular mortality and morbidity
• To show that lenient rate control is not inferior to strict rate control in terms of all cause mortality, cardiovascular hospitalizations, NYHA class for exercise tolerance, left ventricular function and left atrial size, quality of life, neurohormonal activation as measured by NT-proBNP, hospitalization for heart failure, syncope, sustained ventricular tachycardia, appropriate shocks or anti-tachycardia pacing of ICD for ventricular arrhythmias, cardiac arrest, and pacemaker implantations, stroke, systemic emboli, and bleeding, unstable angina pectoris and myocardial infarction, costs and renal function

Inclusion criteria

• Patients with a current episode of permanent AF < 12 months.
• Age </= 80 years.
• Mean resting heart rate > 80 beats per minute with or without rate control medication
• Oral anticoagulation (or aspirin if no risk factors for thromboembolic complications are present).

Exclusion criteria

• Paroxysmal AF
• Known contra-indications for either strict or lenient rate control (e.g. previous adverse effects on negative chronotropic drugs).
• Unstable heart failure defined as NYHA IV heart failure and heart failure necessitating hospital admission < 3 months before inclusion.
• Cardiac surgery < 3 months.
• Any stroke.
• Current or foreseen pacemaker and/ or cardiac resynchronization therapy.
• Signs of sick sinus syndrome or AV conduction disturbances (i.e. symptomatic bradycardia or asystole > 3 seconds or escape rate < 40 beats per minute in awake symptom-free patients).
• Untreated hyperthyroidism or < 3 months euthyroidism.
• Inability to walk or bike.