The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure

A Randomized, Double-blind, Placebo Controlled Study, Designed to Investigate the Effect of Ranolazine on Left Ventricular Diastolic Function in Patients With Symptomatic AF and Preserved Ejection Function, After the Subject Has Undergone a Successful External Electrical Cardioversion

The purpose of this study is to evaluate the efficacy of ranolazine in the prevention of recurrent atrial fibrillation in post-cardioversion patients with heart failure and preserved ejection fraction.

Inclusion Criteria:

• Male or non-pregnant female > 18 years of age;
• Documentation of heart failure and who are in NYHA class II or III;
• Documented history of symptomatic AF < 6 months in duration at the time of presentation, currently in AF at the time of the external electrical cardioversion, and successfully restored to normal sinus rhythm;
• Percutaneous coronary intervention (PCI) patients who can be placed on anticoagulation with warfarin post-cardioversion (and not on rivaroxaban or dabigatran);
• Demonstration of preserved ejection fraction (EF) by echocardiography;
• Echocardiographic evidence of impaired diastolic filling.

Exclusion Criteria:

• Known history of permanent or long-standing AF (> 6 months);
• Other acutely reversible causes of AF, including but not limited to: hyperthyroidism, pericarditis, myocarditis or pulmonary embolism;
• Known history of cirrhosis;
• NYHA Class IV;
• Myocardial Infarction, unstable angina, or coronary artery bypass graft surgery within three months prior to screening;
• Percutaneous coronary intervention (PCI) within 4 weeks prior to screening, if these patients need to be placed on rivaroxaban or dabigatran post-cardioversion;
• Clinically significant valvular disease;
• Clinically significant pulmonary disease;
• Stroke within 3 months prior to screening;
• Creatinine clearance < 30 mL/min as calculated by Cockcroft-Gault formula;
• Use of anti-arrhythmic drugs (Class Ia or IIIc) within 3 months prior to screening;
• Concurrent use of drugs considered strong inhibitors of CYP3A;
• Concurrent use of drugs considered as CYP3A inducers;
• Prior treatment with ranolazine.