The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Atrial Fibrillation, Heart Failure
In brief
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.
Key facts
- Study ID
- NCT01887353
- Run by
- Intermountain Health Care, Inc.
- People needed
- 8
- Starts
- 2013-06-01
- Expected to finish
- 2014-02-01
- Last updated by the study team
- 2015-07-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Intermountain Medical Center — Murray, Utah, United States
Full record on ClinicalTrials.gov
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