The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure

• Status: Terminated
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Intermountain Health Care, Inc.
• Collaborator: Gilead Sciences
• Treatments: Ranolazine

Criteria

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.