Oklahoma City, Oklahoma 73104


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - 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


NCT ID:

NCT01349491


Primary Contact:

Principal Investigator
Udho Thadani, MD
University of Oklahoma

Stavros Stavrakis, MD
Phone: 405-313-2197
Email: Stavros-Stavrakis@ouhsc.edu


Backup Contact:

N/A


Location Contact:

Oklahoma City, Oklahoma 73104
United States

Stavros Stavrakis, MD
Phone: 405-313-2197
Email: Stavros-Stavrakis@ouhsc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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