Status:
TERMINATED
The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure
Lead Sponsor:
Intermountain Health Care, Inc.
Collaborating Sponsors:
Gilead Sciences
Conditions:
Atrial Fibrillation
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01887353
Start Date
June 1 2013
End Date
February 1 2014
Last Update
July 20 2015
Active Locations (1)
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1
Intermountain Medical Center
Murray, Utah, United States, 84107-5701