Ranolazine for the Prevention of Atrial Fibrillation After Electrical Cardioversion
- Registration Number
- NCT01349491
- Lead Sponsor
- University of Oklahoma
- Brief Summary
The investigators hypothesize that ranolazine would decrease the incidence of recurrence of Atrial Fibrillation (AF) after electrical cardioversion of persistent AF. Patients with persistent AF who are candidates for electrical cardioversion will be randomized to either placebo or ranolazine after successful electrical cardioversion.
- Detailed Description
Atrial fibrillation (AF) is the most common clinically significant cardiac arrhythmia and is associated with increased cardiovascular morbidity and mortality. Although a rhythm control strategy offers no survival benefit over a rate control strategy, elective electrical cardioversion is still recommended in patients without hemodynamic instability for symptomatic relief. However, recurrences are frequent after cardioversion and antiarrhythmic medications are required to maintain sinus rhythm. Nonetheless, the use of antiarrhythmic medications is problematic because of the risk of serious potential adverse effects, including drug-induced ventricular arrhythmias.
Ranolazine is a novel antianginal agent, which inhibits the late inward sodium current and produces antiischemic effects without reducing heart rate or blood pressure. Additionally, recent preclinical as well as preliminary clinical data suggest that ranolazine exhibits distinct antiarrhythmic properties. However, there is no controlled data for the use of ranolazine to prevent recurrence of AF after electrical cardioversion of persistent AF.
The investigators hypothesize that ranolazine would decrease the incidence of recurrence of AF after electrical cardioversion of persistent AF. Patients with persistent AF who are candidates for electrical cardioversion will be randomized to either placebo or ranolazine after successful electrical cardioversion. They will be followed at 2 weeks, 1, 3 and 6 months for clinical evaluation and electrocardiography for the detection of recurrence of AF.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
- Male or female with persistent atrial fibrillation, aged 21 or older
- Duration of atrial fibrillation less than one year
- The patient does not have any contraindications for anticoagulation
- The patient is willing to participate in the study for a total of 6 months with 3 outpatient office visits
- The patient has provided written informed consent during the screening visit to any test or procedure being performed, or medication being changed, for this study.
- The patient has no clinically significant abnormal clinical laboratory values, which in the investigator's opinion precludes the patient from safely participating in the study.
- Any contraindication for anticoagulation
- New York Heart Association class IV heart failure
- Currently taking anti-arrhythmic drugs
- Chronic kidney disease (serum creatinine less than 2.5mg/dL) or severe liver dysfunction
- Pregnancy/nursing
- Prolonged QT interval (>500ms)
- Taking other medications known to prolong the QT interval
- Taking other medications known to affect the metabolism of ranolazine
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Matching placebo Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion. Ranolazine Ranolazine Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated.
- Primary Outcome Measures
Name Time Method Primary Outcome - Number of Participants With Atrial Fibrillation 6 months To determine if ranolazine is effective in decreasing recurrences of AF in patients with persistent AF successfully treated with electrical cardioversion.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
OU Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma City VA Medical Center
🇺🇸Oklahoma City, Oklahoma, United States