The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure

NCT ID: NCT01887353

Last Updated: 2015-07-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-02-28

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.

Conditions

Atrial Fibrillation; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ranolazine

Group Type: ACTIVE_COMPARATOR

Ranolazine

Intervention Type: DRUG

Patients will take ranolazine 1000 mg tablets twice daily

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.

Interventions

Ranolazine

Patients will take ranolazine 1000 mg tablets twice daily

Intervention Type: DRUG

Placebo

Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.

Intervention Type: DRUG

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;
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

Intermountain Health Care, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

T. Jared Bunch, MD

Role: PRINCIPAL_INVESTIGATOR

Intermountain Medical Center

Locations

Intermountain Medical Center

Murray, Utah, United States

Countries

United States

Other Identifiers

1024475

Identifier Type: -

Identifier Source: org_study_id