The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Atrial Fibrillation, Heart Failure

Intervention / Treatment
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* Drug: Ranolazine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ranolazine<br> | Drug: Ranolazine<br>* Patients will take ranolazine 1000 mg tablets twice daily<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Atrial Fibrillation (AF) Recurrence | There were too few participants for an assessment of time to first recurrence, therefore the numbers of participants with recurrence up to 6 months is reported instead | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ranolazine, atrial fibrillation, heart failure, cardioversion, persistent AF, paroxysmal AF