The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure
Status: | Terminated |
---|---|
Conditions: | Atrial Fibrillation, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | June 2013 |
End Date: | February 2014 |
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.
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.
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