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

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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

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.
We found this trial at
1
site
5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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