The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure (RAD HF)

Intermountain Health Care, Inc.

Status and phase

Terminated

Phase 2

Conditions

Atrial Fibrillation

Heart Failure

Treatments

Drug: Placebo

Drug: Ranolazine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01887353

1024475

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.