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

Intermountain Health Care, Inc.1 site in 1 country8 target enrollmentJune 2013

ConditionsAtrial Fibrillation Heart Failure

InterventionsRanolazine Placebo

DrugsRanolazine Placebo

Overview

Phase: Phase 2
Intervention: Ranolazine
Conditions: Atrial Fibrillation
Sponsor: Intermountain Health Care, Inc.
Enrollment: 8
Locations: 1
Primary Endpoint: Time to First Atrial Fibrillation (AF) Recurrence
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2013

End Date

February 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Intermountain Health Care, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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;

Arms & Interventions

Ranolazine

Intervention: Ranolazine

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Time to First Atrial Fibrillation (AF) Recurrence

Time Frame: up to 6 months

There were too few participants for an assessment of time to first recurrence, therefore the numbers of participants with recurrence up to 6 months is reported instead