Comparison of Ivabradine effect versus placebo on ventricular rate in patients with non-paroxysmal atrial fibrillation under standard medical treatment

Evaluation of Ivabradine effect on ventricular rate in non-paroxysmal atrial fibrillation patients

Two arm parallel group randomized trial with blinded post treatment care and outcomes assessment

Non-paroxysmal atrial fibrillation patients with ventricular rate of more than 70 , referred to the Loghman Hospital in Tehran who are eligible for the trial , randomized in to Ivabradine and placebo group.24 hours heart rhythm monitoring is performed before and after one month of intervention. Non of Patients or researchers or outcome assessors or statistical analyzers know who received the medication or placebo.

Inclusion criteria Non-paroxysmal atrial fibrillation at randomization, with no prospect of cardioversion, antiarrhythmic treatment with group I or III drugs, or pulmonary vein ablation Beta-blocker or nondihydropyridine calcium channel blocker or digoxin therapy at the maximum dose recommended for or tolerated by the patient ventricular rate of more than 70 Be able to voluntarily give informed consent Exclusion criteria Medical causes that explain poor heart rate control: fever, anemia, hyperthyroidism ,etc patients with a known contraindication to Ivabradine Valve disease requiring surgical or percutaneous repair Impossibility to attend the visits scheduled in the protocol

Non-paroxysmal atrial fibrillation patients with ventricular rate of more than 70

Mean 24 hours ventricular rate before and one month after intervention Mean daytime ventricular rate before and one month after intervention Mean night time ventricular rate before and one month after intervention

The simple randomization method will be done via random number table ،individually, and each patient have her/his own code. The first 50 extracted numbers from 100, (for example numbers 19, 07,02, and 20, …) , will be placed in the drug receiving group, and the rest, (for example, 01,03,05,06,13 , …) in the placebo group. Then, by referring to the clinic, patients who are eligible for trial will be assessed in the order of entry number based on the framework specified in the target groups.

Patients do not know whether they have received medication or a placebo Researchers, outcome assessors, and statistical analyzers are not aware of which patients received the Ivabradine or placebo. .